BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR3 DEFIB, ECG US ENGLISH (T) EXCHANGE

    MDR report key: 11992571 · Received June 14, 2021

    Report

    Report Number
    3030677-2021-12186
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838049994
    PMA / PMN Number
    P160028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DEVICE IS DRAINING BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890274 FR3 DEFIB, ECG US ENGLISH (T) EXCHANGE AED MKJ PHILIPS NORTH AMERICA LLC 861389 00884838049994

    Patients

    Seq Age Sex Outcome Treatment
    1