BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2102888 · Received May 4, 2011

    Report

    Report Number
    2023988-2011-00009
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES SD
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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

    OLM INTRACRANIAL PRESSURE MONITORING KIT (ICP 110-4B) WAS INSERTED. THE INTRACRANIAL MONITOR STOPPED DISPLAYING A READING AFTER FIVE HOURS. THE STAFF CONNECTED ONE OF THEIR OWN CATHETERS TO THE MONITOR AND IT WORKED FINE. THE CATHETER WAS REPLACED. THE PT DID NOT INCUR AN INJURY AS A RESULT OF THIS EVENT. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEUROSCIENCES SD

    Patients

    Seq Age Sex Outcome Treatment
    1