BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2275674 · Received September 19, 2011

    Report

    Report Number
    2023988-2011-00028
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 19, 2011
    Manufacturer
    INTEGRA, SAN DIEGO
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    DURING CALIBRATION THE ICP PROBE OF THE OLM INTRACRANIAL PRESSURE MONITORING KIT COULD NOT BE CALIBRATED. WHEN THE MONITOR WAS USED WITH ANOTHER PROBE THE UNIT FUNCTIONED PROPERLY. THERE WAS A DELAY IN SURGERY HOWEVER, THE AMOUNT OF TIME THE SURGERY WAS DELAYED WAS NOT AVAILABLE. THE PRODUCT WAS IN CONTACT WITH THE PT AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA, SAN DIEGO 305000210563

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR