BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8250200 NIM-RESPONSE PATIENT

    MDR report key: 2471604 · Received February 28, 2012

    Report

    Report Number
    1045254-2012-00036
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Report Date
    February 3, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVENT DATE PROVIDED. NO FAULT WAS FOUND. NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. NEITHER APPLICABLE IMAGING FILMS, NOR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS DEVICE WAS IN AN "AS RECEIVED CONDITION". THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT ISSUE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. WITHOUT INFORMATION TO REASONABLY SUGGEST A SERIOUS INJURY OR MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. DEVICE ANALYSIS BY QUALITY ENGINEER - BECAUSE THE NIM INTERFACE (B)(4) IS AN OBSOLETE PRODUCT THAT IS NO LONGER SUPPORTED IN SERVICE & REPAIR, NO REPAIRS WERE MADE TO THE UNIT. THIS INTERFACE WAS RETURNED ALONG WITH A NIM-RESPONSE 2.0 MAINFRAME. THE NIM-RESPONSE 2.0 IFU WAS REVIEWED. APPENDIX A OF THE IFU CONTAINS A LIST OF NIM-RESPONSE 2.0 SYSTEM COMPONENTS. THIS LIST DOES NOT INCLUDE THE (B)(4) INTERFACE; HOWEVER, THE NIM-RESPONSE 2.0 PATIENT INTERFACE IS LISTED. IN THE WARNINGS AND PRECAUTIONS SECTION OF THE IFU, ADDITIONAL PRECAUTION AP7 STATES, "THE NIM-RESPONSE 2.0 SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. IF ADJACENT OR STACKED USE IS NECESSARY, THE NIM-RESPONSE 2.0 SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED." BASED ON THE INFORMATION OBTAINED FROM THE IFU, THIS NIM INTERFACE SHOULD NOT BE USED WITH THE NIM-RESPONSE 2.0 MAINFRAME. IN THE SERVICE REPORT FOR THE MAINFRAME THE REPAIR TECHNICIAN NOTED THAT "BENT PRONGS" WERE FOUND ON THE PATIENT INTERFACE (PI) CABLE. DEVICE DESCRIPTION - THE PATIENT INTERFACE AND CABLE PROVIDE THE MEANS FOR CARRYING ELECTROMYOGRAPHIC ACTIVITY FROM THE PATIENT'S INNERVATED MUSCLES TO THE CONSOLE, AN INTERFACE FOR CARRYING STIMULATION SIGNALS FROM THE CONSOLE TO THE STIMULATING PROBES/ELECTRODES, AND AN INTERFACE TO THE CONSOLE FROM THE INCREMENTING PROBE. THE PATIENT INTERFACE HAS FOUR OR EIGHT COLOR CODED PAIRS OF PATIENT ELECTRODE JACKS, A PATIENT ELECTRODE GROUND JACK, ONE STIMULUS RETURN JACK, TWO STIMULUS OUTPUT JACKS (CONFIGURED TO ACCEPT MONOPOLAR OR BIPOLAR STIMULATING PROBES), AND ONE INCREMENTING PROBE JACK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED PROCEDURE THE NERVE MONITORING UNIT: "WORKS AND FINDS THE NERVE THEN STOPS WORKING." NO REPORT OF PATIENT INJURY. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE 8250200 NIM-RESPONSE PATIENT STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8250200 38154300

    Patients

    Seq Age Sex Outcome Treatment
    1 NIM RESPONSE 2.0 MAINFRAME