BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP

    MDR report key: 2974068 · Received February 22, 2013

    Report

    Report Number
    0001811755-2013-00350
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORE CONSOLE WAS CLEANED, LUBRICATED, ADJUSTED AND RETURNED TO CIRCULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRYKER LOANER CORE CONSOLE WITH IRRIGATION PUMP FAILED A CHASSIS EARTH LEAKAGE TEST. THE EVENT OCCURRED DURING A ROUTINE TESTING PRIOR TO CIRCULATION. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78915 CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1