BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4 MULTI STATION BATTERY CHARGER

    MDR report key: 2896520 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04117
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 30, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYA
    PMA / PMN Number
    K002348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVAL, THE CORD WAS FOUND TO HAVE HEAT DAMAGE IN ADDITION TO THE MODULES. THE HEAT DAMAGE ON THE CORD WAS IDENTIFIED AS A POSSIBLE CAUSE OF THE HEAT DAMAGE ON THE MODULES, DUE TO POSSIBLE ARCING WHEN THE CORD WAS PLUGGED INTO THE OUTLET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HEAT DAMAGE FOUND ON THE MULTI STATION BATTERY CHARGER WHICH WAS LOCATED IN THE CHARGING ROOM AT THE USER FACILITY. NO PT 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
    1 T4 MULTI STATION BATTERY CHARGER FYA STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK