BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 DEFIBRILLATOR/MONITOR

    MDR report key: 20350900 · Received October 2, 2024

    Report

    Report Number
    0003015876-2024-02773
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 2, 2024
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873905609
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A STRYKER FIELD SERVICE REPRESENTATIVE (FSR) EVALUATED THE CUSTOMER'S DEVICE AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE STRYKER FSR FOUND THAT THE SYSTEM/INTERFACE FEX CABLE WAS DISCONNECTED FROM THE SYSTEM PCB ASSEMBLY. THE CABLE WAS RESEATED TO RESOLVE THE REPORTED ISSUE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS, SUBSEQUENTLY, RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON. AS A RESULT, DEFIBRILLATION WOULD NOT BE AVAILABLE, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369854 LIFEPAK(R) 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873905609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown