BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED PHILIPS ADULT SMART PADS CARTRIDGE

    MDR report key: 15067543 · Received July 19, 2022

    Report

    Report Number
    MW5111000
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    July 18, 2022
    Report Date
    July 18, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105970 AED PHILIPS ADULT SMART PADS CARTRIDGE AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHILIPS NORTH AMERICA LLC. M5071A ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose