MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC. AED PHILIPS ADULT SMART PADS CARTRIDGE; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number M5071A

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 07/18/2022

Event Type  malfunction  

Event Description

(b)(4) is continuing to sell recalled aed pads as part of recall number z-0881-2022, recall event id 89672, and pma number p160029.They said only certain lots were affected but said they could not provide any documentation to show that the aed pads sold to us were not a part of that lot.In fact, all lots have been recalled.Fda safety report id# (b)(4).

• Brand Name: AED PHILIPS ADULT SMART PADS CARTRIDGE
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC.
• MDR Report Key: 15067543
• MDR Text Key: 296375870
• Report Number: MW5111000
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M5071A
• Device Lot Number: ALL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose