BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20E DEFIBRILLATOR/MONITOR

    MDR report key: 23913027 · Received December 29, 2025

    Report

    Report Number
    0003015876-2025-02748
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 29, 2025
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873887707
    PMA / PMN Number
    K130454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STRYKER ADVISED THE CUSTOMER OVER THE PHONE TO TRY A DIFFERENT THERAPY CABLE. THE STRYKER SPECIALIST ALSO INFORMED THE CUSTOMER THAT REPAIRS FOR DEVICES OF THIS AGE ARE UNAVAILABLE AND RECOMMENDED REMOVING THE DEVICE FROM SERVICE IF THE SUGGESTED SOLUTION DOES NOT WORK. THE DEVICE WAS NOT RETURNED TO STRYKER TO EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DOES NOT RECOGNIZE THE THERAPY CABLE. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083166 LIFEPAK 20E DEFIBRILLATOR/MONITOR AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. - 3015876 20E 00883873887707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown