BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INTERNAL DEFIBRILLATION PADDLES, LP20

    MDR report key: 22059356 · Received May 21, 2025

    Report

    Report Number
    22059356
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 12, 2025
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE HAVE HAD FOUR STRYKER LIFEPAK 20E INTERNAL HANDLES/PADDLES BREAK WITHIN 3-4 MONTHS OF PURCHASING THEM. THREE OF THE PADDLES CRACKED ON THE PADDLE ITSELF, WHERE THE PLASTIC MEETS THE METAL PADDLE, AND THE FOURTH HAD A PART OF THE RUBBER HANDLES BREAK OFF. THESE HAVE BEEN TAKEN OUT OF SERVICE AND RETURNED TO STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938042 STRYKER INTERNAL DEFIBRILLATION PADDLES, LP20 DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC. 11131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown