BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    MDR report key: 2469661 · Received February 27, 2012

    Report

    Report Number
    1045254-2012-00033
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Report Date
    February 2, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS DEVICE WAS OUT OF SPECIFICATION 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. NO EVENT DATE PROVIDED. SERVICE AND REPAIR DEPARTMENT REPLACED A SHORTED CABLE AND TESTED IT TO SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED SURGERY THE NERVE MONITORING SYSTEM: "STOP(PED) WORKING IN THE MIDDLE OF A CASE, BUT NO PATIENT INJURY." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE 8252800 RESPONSE 2.0 INCREMENT STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8252800 48961100

    Patients

    Seq Age Sex Outcome Treatment
    1