BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 CHARGER

    MDR report key: 2132328 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02137
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOST LIKELY CAUSE OF THE FAILURE WAS THE PROTECTION CIRCUIT WITHIN THE CHARGER POTENTIALLY DETERMINED THE POWER SUPPLY WAS UNABLE TO SAFELY MEET THE CURRENT DRAW AND SHUT DOWN THE CHARGING CIRCUITRY. THE BATTERIES WERE SUBJECTED TO EXTENDED EXPOSURE TO HIGH VOLTAGE, FROM THE BATTERY CHARGER RESETTING CONTINUOUSLY BECAUSE ALL FOUR BATTERIES WERE INITIALIZING AT THE SAME TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERIES MELTED WHILE BEING CHARGED. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 CHARGER KIJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK