BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 CHARGER

    MDR report key: 2223238 · Received August 16, 2011

    Report

    Report Number
    1811755-2011-03013
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 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 AFFECTED MODULES WERE REPLACED. ADDITIONAL PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE DEVICE WAS RETURNED TO THE ACCOUNT.

    Description of Event or Problem · 1

    THE DEVICE WAS SENT IN FOR REPAIR, AND DURING THE REPAIR PROCESS IT WAS DETERMINED THAT TWO OF THE INTERNAL MODULES HAD BURNT COMPONENTS. THERE WAS NO PATIENT 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