BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 2975456 · Received February 7, 2013

    Report

    Report Number
    2023988-2013-00002
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K853864
    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 INFORMATION.

    Description of Event or Problem · 1

    A 1104 B OLM INTRACRANIAL PRESSURE (ICP) MONITORING KIT WAS INVOLVED IN AN EVENT WHICH WAS DESCRIBED AS FOLLOWS; THE UNIT WAS PLACED IN THE PATIENT IN THE OPERATING ROOM (OR) AND A FEW HOURS LATER IN INTENSIVE CARE UNIT (ICU) IT WAS READING NEGATIVE NUMBERS. ACCORDING TO THE NURSE, THE PATIENT HAD NOT BEEN TURNED OR MOVED. THE PATIENT WAS THEN TAKEN FOR A CAT SCAN AND THE ICP WAS REMOVED. IT WAS DECIDED NOT TO REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53331 OLM INTRACRANIAL PRESSURE MONITORING KIT NA GWM INTEGRA NEUROSCIENCES CA/USA 305000227790 PROBABLY

    Patients

    Seq Age Sex Outcome Treatment
    1