BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LICOX OXYGEN MICRO-PROBE

    MDR report key: 533483 · Received January 22, 2004

    Report

    Report Number
    9617494-2004-00005
    Event Type
    Malfunction
    Date Received
    January 22, 2004
    Date of Event
    December 26, 2003
    Report Date
    January 22, 2004
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDER
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DEVICE WAS PLACED ON A PT WITH SUBARACHNOID HEMORRHAGE. THE DEVICE AND THE VENTRICULAR CATHETER WERE PLACED IN 2003. APPROX 3 TO 4 HOURS AFTER PLACEMENT, THE CC1.SB (OXYGEN PROBE) WAS READING 8MM. THE PT RECEIVED A 50% OXYGEN CHALLENGE WITH NO CHANGE IN THE OXYGEN READING. THE PT EXHIBITED LOW BLOOD PRESSURE READING. VARIOUS MEDICATIONS WERE USED TO RAISE THE PT'S BLOOD PRESSURE. A CT SCAN WAS PERFORMED TO CONFIRM PLACEMENT OF THE OXYGEN PROBE. THE PROBE WAS CORRECTLY PLACED. OVER THE NEXT SIX HOURS THE OXYGEN READING WAS UP TO 18MM AND VARIED FROM 18 TO 27 OVER THE NIGHT. THE TEMPERATURE AND ICP PROBES ON THE DEVICE WERE FUNCTIONING AS DESIRED. THE NEXT DAY AT 8:30 AM THE TREATING NURSE WENT TO LINK THE DEVICE TO THE HP SYSTEM. THE OXYGEN PROBE WAS DISCONNECTED AND THEN RE-CONNECTED AND READ 0MM. THE CABLES WERE CHECKED, EXCHANGED AND CONNECTED TO THE GROUND WIRE. NO CHANGE WAS NOTED ON THE OXYGEN PROBE. DEVICE WAS THEN REMOVED. A NEW ONE WAS PLACED USING A NEW PLACEMENT SITE. THE CC1.SB FROM LOT NUMBER 080903 FUNCTIONED AS DESIRED. AFTER THE OXYGEN CHALLENGE THE READINGS WENT FROM 18 TO 24MM. THE TREATING STAFF IS NOT USING THE HP LINK. THE PROBES ARE STILL IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LICOX OXYGEN MICRO-PROBE LICOX BRAIN TISSUE OXYGEN MONITORING SYS GWM GESELLSCHAFT FUR MEDIZINISCHE SONDER * 080903

    Patients

    Seq Age Sex Outcome Treatment
    1 *