BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 5915628 · Received August 30, 2016

    Report

    Report Number
    1045254-2016-00276
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Report Date
    August 5, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS 8253200: PATIENT INTERFACE RESPONSE 3.0, SERIAL # (B)(4), LOT # 205761130, MANUFACTURED DATE -MARCH/12/2012, 510(K) # K083124 8220325: NIM MUTING PROBE, LOT # 66900000, MANUFACTURED DATE - MARCH/25/2010, 510(K) # K083124. THE NIM MAINFRAME (PART # 8253001), NIM PATIENT INTERFACE (PART # 8253200) AND NIM MUTING PROBE (PART # 8220325) WERE RETURNED FOR EVALUATION. EVALUATION OF THE MAINFRAME (PART # 8253001) COULD NOT DUPLICATE CUSTOMER'S ISSUE ¿NOT REGISTERING STIMULUS WHEN CHECKING WITH PROBE.¿ AS A PRECAUTIONARY MEASURE THE DEVICE WAS PLACED IN THE BURN IN FOR 24 HOURS ATTEMPTING TO OBSERVE ANY HEAT FAILURES. THE DEVICE DID NOT FAIL. EVALUATION FOUND NO FAULT WITH THE DEVICE. THE DEVICE TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF PATIENT INTERFACE (PART # 8253200) COULD NOT DUPLICATE CUSTOMER'S ISSUE ¿NOT REGISTERING STIMULUS WHEN CHECKING WITH PROBE.¿ THE WAVE WASHERS WERE PLACED DUE TO LOOSE CABLE CLIP. THERE WAS NO FUNCTIONAL FAULT WITH THE DEVICE. THE DEVICE TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF MUTING PROBE (PART #8220325) COULD NOT DUPLICATE CUSTOMER'S ISSUE ¿NOT REGISTERING STIMULUS WHEN CHECKING WITH PROBE.¿ THE DEVICE HAD A BROKEN FERRITE. THE BROKEN FERRITE COULD NOT BE REPAIRED, THE DEVICE WAS SCRAPPED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT REGISTERING STIMULUS WHEN CHECKING WITH THE PROBE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564706 NIM® 3.0 MAINFRAME STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253001 66967100

    Patients

    Seq Age Sex Outcome Treatment
    1