BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 35 DEFIBRILLATOR/MONITOR

    MDR report key: 24218030 · Received January 29, 2026

    Report

    Report Number
    0003015876-2026-00223
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    December 2, 2025
    Report Date
    May 28, 2026
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    P160026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDWATCH REPORT INDICATES THE DEVICE WAS POWER CYCLED AND THEREAFTER WORKED AS EXPECTED AND WAS SUBSEQUENTLY RETURNED TO STRYKER. IT IS NOT POSSIBLE TO CONFIRM THESE STATEMENTS WITHOUT THE DEVICE SERIAL NUMBER/ADDITIONAL INFORMATION. STRYKER CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 0

    STRYKER RECEIVED MEDWATCH REPORT 5180144 FROM THE FDA, INDICATING A CUSTOMER REPORTED THEIR DEVICE WOULD NOT DISPLAY AN EKG. AS A RESULT, DEFIBRILLATION THERAPY MAY BE DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250171 LIFEPAK® 35 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 35

    Patients

    Seq Age Sex Outcome Treatment
    1