BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT

    MDR report key: 3960594 · Received June 20, 2014

    Report

    Report Number
    8010219-2014-00026
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    May 28, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD
    Product Code
    GWM
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNK DATE, THE MONITOR HAD A "FUZZY" SCREEN. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION BUT TO DATE, NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363420 CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT NA GWM INTEGRA NEUROSCIENCES, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1