BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253001IP RESPONSE 2.0

    MDR report key: 3030069 · Received April 2, 2013

    Report

    Report Number
    1045254-2013-00315
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: INTERFACE 8252800 RESPONSE 2.0 INCREMENT, S/N (B)(4), LOT 43168800, THE MANUFACTURING DATE FOR THIS DEVICE HAS BEEN CONFIRMED TO BE MARCH 03, 2006. (B)(4) EVALUATION SUMMARY: DURING PRODUCT EVALUATION, IT WAS IDENTIFIED THAT THE TOUCHSCREEN ON THE MAINFRAME COULD NOT CALIBRATE; THE TOUCHSCREEN AND A MISSING RUBBER FOOT WERE REPLACED ON THAT UNIT. ON THE PATIENT INTERFACE THE CABLE WAS IDENTIFIED AS UNRESPONSIVE; THE CABLE WAS REPLACED ON THAT UNIT. THE DEVICES WERE TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. RESULTS: MAINFRAME: FAILURE TO CALIBRATE; INTERFACE: INTEROPERABILITY PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIM (NERVE INTEGRITY MONITOR) UNIT HAS ERRATIC OPERATION PROBLEMS; CHANNEL 1 IS NOT WORKING SOMETIMES AND WHEN SETTING THE STIMULATOR THE LEVEL WOULD GO TO ZERO BY ITSELF, THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134288 MAINFRAME 8253001IP RESPONSE 2.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252001IP 43101100

    Patients

    Seq Age Sex Outcome Treatment
    1 INTERFACE 8252800 RESPONSE 2.0 INCREMENT