BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD SMALL ASEPTIC BATTERY

    MDR report key: 3163328 · Received June 11, 2013

    Report

    Report Number
    0001811755-2013-01334
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    May 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    UPON DEVICE EVALUATION IT WAS CONFIRMED THAT THERE WAS THERMAL DAMAGE TO THE BATTERY. INTERNAL INSPECTION IDENTIFIED THERMAL DAMAGE OF THE FUSE STRAP, WHICH IS THE PROBABLE CAUSE OF THE REPORTED OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE THE DEVICE WAS OVERHEATING. 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 DURING TESTING CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE THE DEVICE WAS OVERHEATING. 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
    264642 CD SMALL ASEPTIC BATTERY ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO 12291

    Patients

    Seq Age Sex Outcome Treatment
    1