BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INTERFACE 8253200 RESPONSE 3.0

    MDR report key: 2883170 · Received December 21, 2012

    Report

    Report Number
    1045254-2012-00750
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND PRODUCT EVALUATION IS CURRENTLY UNDERWAY. RESULT: RESULTS PENDING COMPLETION OF EVALUATION. CONCLUSION: NOT YET AVAILABLE, EVALUATION IN PROGRESS. METHOD: NO TESTING METHODS PERFORMED. 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. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THIS PRODUCT WAS BEING USED FOR TREATMENT NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUTION WAS COMPLETED. IT WAS FOUND THE PATIENT INTERFACE CABLE WAS NOT WORKING PROPERLY DUE TO THE CABLE SHORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY OR WAS BROKEN (NON-SPECIFIC). NOT WORKING PROPERLY OR BROKEN (NON-SPECIFIC) COULD POTENTIALLY CAUSE INJURY TO THE PATIENT BY FAILING TO IDENTIFY A NERVE. THIS COULD RESULT IN THE SURGEON DAMAGING THE NERVE. THERE WAS NO REPORT OF ANY PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT INTERFACE 8253200 RESPONSE 3.0 STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8253200 72722200

    Patients

    Seq Age Sex Outcome Treatment
    1