BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT PRESSURE MONITOR

    MDR report key: 207912 · Received January 25, 1999

    Report

    Report Number
    2023988-1999-00003
    Event Type
    Malfunction
    Date Received
    January 25, 1999
    Date of Event
    January 11, 1999
    Report Date
    January 25, 1999
    Manufacturer
    NEUROCARE GROUP, CAMINO
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRACRANIAL PRESSURE VALUE WAS ABOUT -50 ON NOVEMBER 13, WHEN THE 10 DAYS PASSED SINCE WE STARTED TO USE 110-4HMT. WHEN WE REPLACED THE MONITOR WITH ANOTHER ONE (MPH-1), WE COULD SEE THE VALUE (ABOUT 25) SAME AS BEFORE. THEREFORE, THERE MAY BE SOMETHING WRONG IN THE MAIN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT PRESSURE MONITOR ICP MONITOR GWM NEUROCARE GROUP, CAMINO V420-9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention