BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15

    MDR report key: 17200221 · Received June 23, 2023

    Report

    Report Number
    MW5118802
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 20, 2023
    Report Date
    June 20, 2023
    Manufacturer
    PHYSIO CONTROL (STRYKER), INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MANUFACTURING DEFECT WITH DEFIBRILLATOR CHARGER/POWER SUPPLY. AFFECTING 16 DEFIBRILLATORS SO FAR. THEY WILL NOT CHARGE AND ALSO PREVENTS THE DEFIBRILLATOR FROM BEING TURNED ON WHEN PLUGGED IN. THERE HAS NOT BEEN PATIENT IMPACTS TO DATE BUT DOES WARRANT POSSIBLE RECALL. REFERENCE REPORTS: MW5118787, MW5118788, MW5118789, MW5118790, MW5118791, MW5118792, MW5118793, MW5118794, MW5118795, MW5118796, MW5118797, MW5118798, MW5118799, MW5118800, MW5118801. REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969220 LIFEPAK 15 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO CONTROL (STRYKER), INC. LIFEPAK 15

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown