BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT.

    MDR report key: 1915330 · Received November 2, 2010

    Report

    Report Number
    8010219-2010-00013
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE CUSTOMER GOT A "STUCK KEYBOARD" ERROR, PROBLEMS BOOTING UP, AND THEN GOT A "CRC MESSAGE" WHILE USING THE PRODUCT. SURGERY WAS COMPLETED AND THERE WAS NO PT INJURY. IT WAS THEN REPORTED THAT THE UNIT COULD NOT PASS THE INITIAL STARTUP SCREEN WHEN IT WAS RESTARTED. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT. NA GWM INTEGRA NEUROSCIENCES, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1