BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8252001IP RESPONSE 2.0 W/INCRE

    MDR report key: 3183064 · Received June 21, 2013

    Report

    Report Number
    1045254-2013-00431
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    IKN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: PATIENT INTERFACE #8252800, SN#(B)(4), LOT#54403000, MFR DATE 02/11/2008. (B)(4). RECEIVED NIM 2.0 MAINFRAME AND INTERFACE FOR EVALUATION BY THE QE AND PRODUCT SPECIALIST IN SERVICE <(>&<)> REPAIR. THE CONDITION OF THE DEVICES SHOWED NO SIGNIFICANT PHYSICAL DAMAGE. THE SPARE FUSE FOR THE PATIENT INTERFACE HAD BEEN MARKED WITH WHAT APPEARED TO BE A BLACK PERMANENT MARKER. EQUIPMENT USED: TEST INCREMENTING PROBES AND PATIENT SIMULATOR (PROVIDED BY S<(>&<)>R). OBSERVATIONS: A SHAKE TEST WAS PERFORMED ON THE MAINFRAME; NO LOOSE PARTS WERE NOTED. THE MAINFRAME WAS POWERED ON; BOOT-UP SEQUENCE WAS COMPLETED. INTERFACE, PROBE, AND SIMULATOR WERE CONNECTED; INTERFACE WAS PLUGGED INTO MAINFRAME. A MONITORING MODE WAS SELECTED USING ALL FOUR CHANNELS. EACH CHANNEL WAS STIMULATED IN TURN USING STIM 1 AND STIM 2; NO RESPONSES OR MEASURED CURRENT WERE SEEN ON ANY CHANNELS WITH EITHER STIM CIRCUIT. THE ELECTRODES WERE TAPPED BY HAND, AND ARTIFACTS WERE DETECTED ON THE CHANNELS. THE INTERFACE¿S FUSES WERE CHECKED AND VISUALLY APPEARED TO BE INTACT. THE PROBE WAS REPLACED, AND THE EVALUATION WAS REPEATED WITH THE SAME RESULTS. THE PRIMARY ROOT CAUSE IS NOT EVIDENT BUT IS LIKELY THE RESULT OF ANTICIPATED USE CHARACTERISTICS. THE MAINFRAME CPU BOARD WAS BAD AND DUE TO THE OLDER MODEL VERSION, THE CPU BOARD COULD NOT BE REPLACED; THE MAINFRAME WAS DEEMED IRREPARABLE. THE INTERFACE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIM SYSTEM WAS RETURNED FOR EVALUATION AND REPAIR WITH A COMPLAINT OF ¿NOT STIMULATING¿. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283414 MAINFRAME 8252001IP RESPONSE 2.0 W/INCRE ELECTROMYOGRAPH, DIAGNOSTIC IKN MEDTRONIC XOMED, INC. 8252001IP 54580500

    Patients

    Seq Age Sex Outcome Treatment
    1