Please refer tothe, If a user has elected to preserve his/her unit and has provided the required information in the Preservation Registry at. In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). How will I receive my Adult SMART pads cartridge? As a first step, if your device is affected, please start the, Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. The replacement device Ive received has the same model number as my affected device. We then thoroughly clean and decontaminate the device, update the firmware, test, and repackage it with a recertified sticker to show that it is ready for use. Also, be sure to keep all packaging materials, as they will be used to return your affected device back to Philips Respironics. To learn more, click here. The relevant regulatory authoritieswere notified of this issue in February 2022. Owners of the HS1/OnSite/Home AEDs who have not received a letter from Philips or a distributor by the end of March 2022 may contact Philips or their local Philips Representative. Although you may feel anxious at the news of the recall, we encourage you to talk to your doctor about the right treatment for you. Key Points Please complete and submit the additional information once you receive the communication. Devices affected by the recall / field safety notice must be serviced only by qualified technicians. Koninklijke Philips N.V., 2004 - 2023. This URGENT Medical Device Recall Letter is intended to inform you about: 1. Further testing and analysis on other devices is ongoing. Insert the bottom end of the new SMART Pads cartridge into the recess, then press in the cartridge until the latch clicks into place. Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). M5071A SMART Pads Cartridge is designed for use in the Philips HeartStart OnSite and HS1 home defibrillator. Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. We ask that patients return their affected units as part of the repair and replacement program related to the recall / field safety notice. While recalled devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and remediated devices is a silicone foam. Philips M5071A Smart Adult Electrode Cartridge for - WebstaurantStore Please continue to follow the recall / field safety notice instructions you have received for affected Philips Respironics Sleep & Respiratory Care devices. We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. This is a potential risk to health. Users should continue to use the HS1 AED and pads as-is, and follow the devices voice prompts during use, because the AED will audibly guide users through each step of the procedure. Patients are advised to log into the Patient Portal to view approximate shipping timeframe of their replacement device. Users should continue to use the HS1 AED and pads as-is, and follow the devices voice prompts during use, because the AED will audibly guide users through each step of the procedure. As a result, testing and assessments have been carried out. Philips continues to fulfill orders for the FRx AED and accessories including SMART Pads II. Please review the DreamStation 2 Setup and Use video for help on getting started. If you have not responded to the request, you will receive a communication shortly asking for some additional information about your HeartStart HS1/OnSite/Home AED(s). Note: If you need help accessing information in different file formats, see AED recall | Philips What if I don't have an extra set of pads? Please review the DreamStation 2 Setup and Use video for help on getting started. Why do these devices require a correction? providing CPR if needed, until Emergency Medical Services Personnel arrive. Philips M5071A HeartStart OnSite Adult SMART Pads - AED Brands Philips AED Recall THE PHILIPS ONSITE AED IS ON NATIONWIDE BACKORDER WITH AN UNKNOWN SHIP DATE. Once you receive your updated Adult SMART pads cartridge, install it into your HS1/OnSite/Home AED. Medical Device Recalls. Instructions for Downloading Viewers and Players. Users should continue to use the HS1 AED and pads as-is and follow the devices voice prompts during use. Devices affected by the recall / field safety notice must be serviced only by qualified technicians. As described in the Instructions For Use (IFU), it is recommended that you store a spare pads cartridge with your HS1 AED. Philips, REF M5071A, Adult. We appreciate your cooperation and patience and encourage you to save your registration confirmation number for future communications. We will share regular updates with all those who have registered a device. Amazon.com: Philips M5071a Pads 03 : 43 : 59 6 results for "philips m5071a pads" Results Philips HeartStart AED Defibrillator Replacement Adult Training Pads 22 $4027 FREE delivery Mon, Jul 17 Or fastest delivery Fri, Jul 14 Philips HeartStart 989803139271 Adult Training Pads II Kit 1 $10900 FREE delivery Mon, Jul 17 Or fastest delivery Fri, Jul 14 Medical Device Recall Information - Philips Respironics Sleep and Once all accessories have been installed, plug in your device to a working wall outlet and wait five minutes for your device settings to upload. health consequences. It is not possible to know prior to patient use if a pad is affected because the pads are protected by a foil seal. Continue using the HS1/OnSite/Home AED and pads as-is and follow the voice prompts because the AED will step the user through the necessary actions. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owners Manual and the Urgent Medical Device Correction Letter/Field Safety Notice. Unlike the DreamStation CPAP device, the DreamStation 2 CPAP Advanced device features the Ramp Plus feature where a user can select a comfortable start pressure. The current pads cartridge LOT # starts with a Y. About Us; Blog; It is not possible to know if your pads are affected by the problem prior to use because the pads are protected by a foil seal. Smart PADS CARTRIDGE , (0-8 YE Philips, REF M5071A, Adult. Philips has an updated Adult SMART pad and expects to submit for clearance by Competent Authorities globally. 1. Between 2010 and 2021, Philips shipped 5 million sets of M5071A and M5072A pads globally. After careful analysis, we issued a Recall Notification in the US and a Field Safety Notice in other markets. We are always interested in engaging with you. Please be assured that we are doing all we can to meet demand, including increasing the production of repair kits and replacement devices. Since then, together with five independent, certified testing laboratories in the US and Europe and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope the potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. How are you removing the old foam safely? Philips M5071A HeartStart OnSite SMART Adult Replacement Cartridge . How long will I have to wait to receive my replacement device? How to change the Philips HeartStart Onsite pads. We do not offer repair kits for sale, nor would we authorize third parties to do so. . Based on the comprehensive testing and analysis that we have done over the past 18 months working with five independent certified laboratories, third-party experts and physicians - we now have a complete set of results for the first-generation DreamStation devices. Your prescription pressure should be delivered at this time. They are not manufactured by Philips Respironics or our partners, and may pose a health hazard if used. The affected products are identified in the tables below: DreamStation ASV DreamStation ST, AVAPS SystemOne ASV4 C-Series ASV C-Series S/T and AVAPS OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go Dorma 400 Dorma 500 REMstar SE Auto, Trilogy 100 Trilogy 200 Garbin Plus, Aeris, LifeVent, A-Series BiPAP Hybrid A30 (not marketed in US) A-Series BiPAP V30 Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). When you receive your replacement device, please first be sure to review all written instructions for setup, cleaning of existing components, and return instructions. If you are used to using a DreamStation CPAP device and have received a new DreamStation 2 CPAP Adanced, this new device has also been set to the same prescription settings as before and is ready for use. This is a potential risk to health. The potential issue is with the foam in the device that is used to reduce sound and vibration. Lift out the used SMART pads cartridge. We are producing and shipping similar CPAP, BiLevel PAP and Mechanical Ventilator platforms with a different design. Out of an abundance of caution, a reasonable worst-case scenario was considered. Please be assured that we are doing all we can to resolve the issue as quickly as possible. FREE SHIPPING on online orders of $99+* 800-544-0048. You can then start to reassemble your replacement device with the accessories you had been using, or new accessories. Susceptibility to Degradation and Volatile Organic Compound Emission . Based on our analysis, the root cause of this issue is related to the sound abatement foam, currently used to reduce noise and vibration in specific identified products of the Sleep & Respiratory Care portfolio. Make sure you have the following items close at hand: Recall Confirmation Form, List of Affected Pad Lot Numbers, Updated Pad dispatch details (M5071A Adult Pads), and your HS1 HeartStart AED (referred to as the AED). We appreciate your cooperation in this effort, and if you have any questions, please contact us at +1-833-262-1871. * As of June 30, 2023 ** A remediated device includes new, recertified, alternative devices sent as replacements for affected units, devices shipped to DMEs who are directly handling patient remediations, and financial payment. Class 2 Device Recall Philips and Laerdal brands of HeartStart HS1 You can read the press release, We understand that the situation may cause you some anxiety and you may feel uncertain about what to do next. Using packing tape supplied, close your box, and seal it. Adult and pediatric pads for HS1/OnSite/Home AEDs are still shipping. Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Why buy from a Licensed Canadian Distributor of AED units. (Most of these reports, approximately 80, were received in 2021.). We are focused on delivering the best care possible, while supporting patients, customers and clinicians throughout the remediation process. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. No. The Philips M5071A replacement pads have a 2-Year Shelf Life if no rescue is required during that time. In some cases, this foam showed signs of degradation (damage) and chemical emissions. What the problem is and under what circumstances it can occur HS1/OnSite/Home AED pads (PN: M5071A, M5072A) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The Philips M5071A HeartStart Adult SMART Pads Cartridge should be replaced every 2 years. Philips - M5071A HS1 Adult SMART Defibrillator Pads Cartridge $75.00. Philips AED pads must be replaced after use or once every 2 years regardless of use. The list of affected devices can be found here. Philips HS1 Trainer, Philips, Guidelines 2005 M5085A $469.00. Please complete this request as soon as possible. Dear Customer, A problem has been identified in the Philips M5071A (adult) and M5072A (infant/child) AED pads that could pose a risk for patients or users. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. At the time of the October 2022 notification update, Philips has received 151 reports about this issue since 2010 out of approximately 5 million shipments of M5071A and M5072A pads. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. Once set, the device will automatically start at the selected Ramp Plus pressure with all future therapy sessions. Product / Device Name / Model # Philips M5071A (adult) and M5072A (infant/child) for use specifically with the HeartStart HS1 AEDs/OnSite/Home AED ARTG Ref # 337264, 374814 . In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). Please read the document provided by Philips in regards to the above recall for detailed description and steps to follow. Since then, together with five independent, certified testing laboratories in the US and Europe and other qualified third-party experts, Philips Respironics has been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope the potential patient health risks related to possible emission of particulates from degraded foam and volatile organic compounds. Please click. URGENT - Medical Device Recall Product: Date: Subject: Philips M5071A (adult) and M5072A (infant/child) AED pads March 2, 2022 . We have noticed an issue with a Philips M5071A (adult) and M5072A (infant/child) AED pads that, if it were to re-occur, could potentially pose a risk for the patient, user and/or bystanders. Customers may contact their local Philips Representative through, Inquire with a Philips healthcare sales rep, Subscribe for regular news and updates from Philips, Get technical support for a healthcare product, Find product documentation and instructions for use. Lift out the used SMART pads cartridge. If you have received an Urgent MedicalDevice Correction/Field Safety Notice letter,here is what you need to do: Complete and return the reply form you received with your letter. Please click here for the latest testing and research information. Philips - M5071A HS1 Adult SMART Defibrillator Pads Cartridge What is the status of the Trilogy 100/200 remediation? What is the issue with the HS1/OnSite/Home AED pads? Please visit theventilation news and updates pageforthe latest status of the Trilogy 100/200 remediation. The initial concern with the foam related to possible emission of particulates (tiny particles) from degraded foam and certain chemicals of concern, called volatile organic compounds (VOCs). This package contains 1 set of M5071A electrode pads. Directions below indicate how to use pads in an emergency. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. No, this issue does not affect the Philips indemnification obligation to users. The foam that is used in some devices to reduce sound and vibration showed signs of degradation (damage) and chemical emissions. Philips Defibrillator Recall | aedusa.com - AED USA Knowledge Our trained service professionals can make sure that the affected foam is completely and safely removed, and that the new silicone foam is inserted correctly. If you need to change your pads in an emergency, there is a short video showing how to replace the pads cartridge at: www.philips.com/replace-aed-pads, Please pass the notice to all those who need to be aware within your organization or to any organization where HS1/Onsite/Home AED devices or pads cartridges have been transferred, (if appropriate.). Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. By clicking on the link, you will be leaving the official Philips Electronics Ltd. ("Philips") website. In the event of significant loss of gel, there is a possibility that the pad may not adhere correctly, or not make effective contact with a patients skin. Further testing and analysis on other devices is ongoing. No, this issue only affects Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A] for use with the HeartStart HS1 Automated External Defibrillator (AED) devices. It is not possible to know if your pads are affected by the problem prior to use because the pads are protected by a foil seal. FAQs. Philips plans to resume shipments of HS1/OnSite/Home AEDs around the time updated pads are available. A discolored, melted appearance does not have any impact on the delivery of therapy; however, there may be a delay of therapy if the user hesitates to apply the pad due to its appearance. If this occurs, the HS1 AED could deliver less effective or ineffective therapy. They are not approved for use by the FDA. Affected AEDs are not recommended to be removed from service. Should I store a spare pads cartridge with my HS1/OnSite/Home AED? Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs. Philips HeartStart Adult SMART Pads are appropriate for cardiac arrest victims 8 years and older, or weighing above 55 pounds. They can help you if you have questions about how to use your replacement device and can troubleshoot and document issues you may be having. The affected products are identified in the tables below: A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP A40 (not marketed in the US), A-Series BiPAP A30 (not marketed in the US), Products that are not affected may have different sound abatement foam material, as new materials and technologies have become available over time. FREE SHIPPING on all Orders over $99.00 (Some Conditions May Apply), Product: Philips M5071A (adult) and M5072A (infant/child) AED pads. Expired pads are not impacted. As described in the Instructions For Use (IFU), it is recommended that you store a spare pads cartridge with your HS1 AED. Class 2 Device Recall PHILIPS ADULT SMART PADS CARTRIDGE. The latest information regarding this action can be found at our publicly available web site: https://www.philips.com/src-update. Dear Customer, A problem has been identified in the Philips M5071A (adult) and M5072A (infant/child) AED pads that could pose a risk for patients or users. Please complete and submit the additional information once you receive the communication. FDA Home; Medical Devices; Databases - 1 to 5 of 5 Results PMA Number: P160029: Results . The AED will audibly guide users through each step of the procedure. If you need to change your pads in an emergency, there is a short video showing how to replace the pads cartridge at: www.philips.com/replace-aed-pads, Please forward the notice to all those who need to be aware within your organization or to any organization where HS1 AED devices or pads cartridges have been transferred, (if appropriate.). If you notice the gel beginning to separate from the foam backing as you peel, try to prevent the gel from folding onto itself if possible. The potential issue is with the foam in the device that is used to reduce sound and vibration. Customers may contact their local Philips Representative as shown in the Field Safety Notice. Customers may contact their local Philips Representative through HS1.canada@philips.com. At the time of the February 2022 issuance of this notification, Philips has received approximately 100 reports about this issue out of approximately 5 million shipments of M5071A and M5072A pads since 2010. DearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTCorrectionisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur HS1/OnSite/HomeAEDpads(PN:M5071A,M5072A)havebeenobservedtoexperiencegelseparationfromthe foam/tinbackingwhenpeele. Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the devices voice prompts during use, because the AED will audibly guide users through each step of the procedure. What should customers or users do? Q&A: Know Your HeartStart Onsite SMART Pads Cartridge When we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them. Has this issue been reported to the FDA or other regulators? Philips or a Philips Distributor will send a letter to the customer of record. What happens if a pad with peeled gel is used on a patient? For questions regarding this recall, please call AED Recall Support at 1-800-263-3342 (Option 6). Is there a safety hazard with these devices? PLEASE CONTACT THE DISTRIBUTOR THAT PROVIDED THE AED, OR PHILIPS DIRECTLY WITH ANY QUESTIONS. We thank you for your patience as we work to restore your trust.