BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800LO LOANER RESP 2.0 IP

    MDR report key: 3027663 · Received March 29, 2013

    Report

    Report Number
    1045254-2013-00312
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    IKN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE UNIT WAS INITIALLY RETURNED FOR EVALUATION/CALIBRATION, HOWEVER ANALYSIS FOUND AN INTERMITTENT SITUATION CAUSED BY A DAMAGED INTERFACE CABLE. THE CABLE WAS REPLACED, THE UNIT WAS TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE AVAILABLE INFORMATION INDICATES THE USER REQUESTED AN EVALUATION OF THEIR DEVICE AS A ROUTINE CALIBRATION. THIS IS THE ONLY INFORMATION AVAILABLE AND NO PATIENT IMPACT OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT. HOWEVER, ON (B)(6) 2013, AN INTERMITTENT SITUATION WAS FOUND THROUGH ANALYSIS AS BEING CAUSED BY A DAMAGED INTERFACE CABLE, WHICH HAS THE POTENTIAL TO LEAD TO FAILURE IN IDENTIFYING A NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131011 INTERFACE 8252800LO LOANER RESP 2.0 IP ELECTROMYOGRAPH, DIAGNOSTIC IKN MEDTRONIC XOMED, INC. 8252800LO 58943300

    Patients

    Seq Age Sex Outcome Treatment
    1