BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP

    MDR report key: 3002692 · Received March 13, 2013

    Report

    Report Number
    0001811755-2013-00521
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE FUNCTIONED NORMALLY AND PASSED ALL TESTING. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN AT THE ACCOUNT IT WAS FOUND THAT THE TECHNICIAN WAS APPLYING THE INCORRECT LIMITS TO THE EARTH LEAKAGE CURRENT TEST PROCEDURE WHICH CAUSED THE TECHNICIAN TO BELIEVE THAT THE LEAKAGE CURRENT WAS TOO HIGH. THE ACCOUNT HAS BEEN NOTIFIED OF THE ISSUE WITH THE TESTING AND THE ENGINEER IS WORKING WITH THEM TO CORRECT THEIR TEST METHODS.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAKAGE CURRENTS WERE TOO HIGH WHEN THE CONSOLE WAS RECEIVED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT WAS ASSOCIATED WITH THE CONSOLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAKAGE CURRENTS WERE TOO HIGH WHEN THE CONSOLE WAS RECEIVED. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT WAS ASSOCIATED WITH THE CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104701 CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, AND THEIR ACCESSORIES HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1