BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K

    MDR report key: 2102908 · Received May 4, 2011

    Report

    Report Number
    2023988-2011-00010
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 4, 2011
    Manufacturer
    INTEGRA, SAN DIEGO
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 INFO.

    Description of Event or Problem · 1

    AN INTRACRANIAL PRESSURE (ICP) MONITORING KIT WAS INVOLVED IN AN EVENT AND WAS DESCRIBED AS FOLLOWS; THE CATHETER WAS ZEROED PRIOR TO INSERTION. WHEN THE CATHETER WAS INSERTED, THE ICP WAS READING 20MMHG. AFTER 1 HOUR, IT BEGAN TO FLUCTUATE BETWEEN 1MMHG AND 3MMHG AS THE THERAPEUTIC HYPOTHERMIA WAS PERFORMED. THE TEMPERATURE WAS FUNCTIONING FINE. THE PHYSICIAN REVISED TO A NEW CATHETER WHICH FUNCTIONED NORMALLY. THERE WAS NO PT INJURY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRACRANIAL PRESSURE / TEMPERATURE MONITORING K NA GWM INTEGRA, SAN DIEGO

    Patients

    Seq Age Sex Outcome Treatment
    1