BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 POWER PACK

    MDR report key: 3023058 · Received March 27, 2013

    Report

    Report Number
    0001811755-2013-00615
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LYU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED THERMAL DAMAGE TO THE PRONG COULD NOT BE CONFIRMED. IT WAS FOUND THAT THE DAMAGE TO THE BATTERY WAS NOT THERMAL DAMAGE. THE DAMAGE MAY HAVE BEEN CAUSED BY FORCE OR IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CHARGING AT THE USER FACILITY, THE PRONG OF THE T4 POWER PACK LOOKED MELTED. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125956 T4 POWER PACK ACCESSORY, SURGICAL APPAREL LYU STRYKER INSTRUMENTS-KALAMAZOO 11341

    Patients

    Seq Age Sex Outcome Treatment
    1