BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 POWER PACK

    MDR report key: 3251762 · Received July 29, 2013

    Report

    Report Number
    0001811755-2013-01783
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 12, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LYU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE REPORTED LEAK WAS NOT CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN. HOWEVER, UPON EVALUATION, DISCOLORATION/STAINING ON THE BATTERY HOUSING AND HOLSTER WAS OBSERVED, WHICH COULD HAVE BEEN PERCEIVED AS LEAKING BY THE CUSTOMER. POSSIBLE CAUSES OF THE DISCOLORATION/STAINING INCLUDE THE AGE OF THE BATTERIES AND/OR THE STORAGE CONDITIONS. THE BATTERY IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNWRAPPING OF THE BATTERY FOR THE FIRST ATTEMPT OF CHARGING OF THE DEVICE, THE BATTERY WAS LEAKING.IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNWRAPPING OF THE BATTERY FOR THE FIRST ATTEMPT OF CHARGING OF THE DEVICE, THE BATTERY WAS LEAKING. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. 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
    353720 T4 POWER PACK ACCESSORY, SURGICAL APPAREL LYU STRYKER INSTRUMENTS-KALAMAZOO 08218

    Patients

    Seq Age Sex Outcome Treatment
    1