BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 510961 · Received January 14, 2004

    Report

    Report Number
    2023988-2004-00010
    Event Type
    Malfunction
    Date Received
    January 14, 2004
    Report Date
    January 14, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTS THE SURGEON PAID ATTENTION NOT TO BEND THE CATHETER DURING INSERTION. JUST AFTER INSERTING THE CATHETER IN THE PT, ADEQUATE VALUES WERE DISPLAYED. HOWEVER, LATER IN THE DAY THE MONITOR DISPLAYED "CHECK CATHETER." THE ADEQUATE INTRACRANIAL PRESSURE WAS DISPLAYED ON THE FIRST DAY OF USE BUT THE TEMPERATURE WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE MONITORING KIT NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W048009

    Patients

    Seq Age Sex Outcome Treatment
    1 *