BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTSWITCH 1895400 XPS

    MDR report key: 3111471 · Received May 14, 2013

    Report

    Report Number
    1045254-2013-00381
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K963246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS REVIEWED AND FOUND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE UNIT'S PUSH BUTTON WAS STUCK/ BROKEN AND THE SEAL WAS TORN. BOTH ITEMS WERE REPLACED. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PREVENTATIVE MAINTENANCE THE FOOTSWITCH HOOVERS AT 60RPMS WITHOUT THE FOOTSWITCH BEING PRESSED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212706 FOOTSWITCH 1895400 XPS DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 1895400 42259900

    Patients

    Seq Age Sex Outcome Treatment
    1