BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 15 DEFIBRILLATOR/MONITOR

    MDR report key: 13973045 · Received April 1, 2022

    Report

    Report Number
    0003015876-2022-00470
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 7, 2022
    Report Date
    March 31, 2022
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873871751
    PMA / PMN Number
    P160026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STRYKER EVALUATED THE CUSTOMER¿S DEVICE AND VERIFIED THE REPORTED ISSUE. STRYKER OBSERVED BATTERY KEP NUTS SPINNING IN BATTERY WELL ONE. STRYKER REPLACED THE REAR CASE TO RESOLVE THE ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE POWERED OFF SEVERAL TIMES DURING THE EVENT. THIS ISSUE IS PATIENT-RELATED; HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2690980 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873871751

    Patients

    Seq Age Sex Outcome Treatment
    1 25 MO Female