BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LICOX OXYGEN MICRO-PROBE G-WM

    MDR report key: 5302530 · Received September 17, 2004

    Report

    Report Number
    9617494-2004-00025
    Event Type
    Malfunction
    Date Received
    September 17, 2004
    Report Date
    September 17, 2004
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK GMS, M
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    PHYSICIAN PLACED THE IM3 BOLT. THE TEMPERATURE PROBE WAS PLACED WITHOUT INCIDENT, HOWEVER, THE OXYGEN PROBE WAS VERY DIFFICULT TO PLACE DOWN THE CHANNEL AND THE PHYSICIAN STRUGGLED TO GET THE PROBE IN PLACE. THE INITIAL OXYGEN READING WAS 0.5MM AND STAYED CONSISTENT FOR 3 HOURS. AN OXYGEN CHALLENGE WAS PERFORMED BUT THE NUMBER ONLY WENT UP TO 1MMHG. IT WAS OBVIOUS THAT THE PROBE WAS NOT WORKING CORRECTLY. ADDITIONAL MANIPULATION OF THE PROBE TO PLACE IT DOWN THE CHANNEL WAS REQUIRED. THE SYSTEM WAS REMOVED AFTER ABOUT FIVE HOURS IN PLACE WITHOUT ACCURATE OXYGEN READINGS. A NEW SYSTEM WAS PLACED IN THE SAME BURR HOLE THAT HAD BEEN MADE IN THE PATIENT'S HEAD. THE NEW OXYGEN PROBE IS READING CORRECTLY AT APPROXIMATELY 30MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LICOX OXYGEN MICRO-PROBE G-WM LICOX BRAIN TISSUE OXYGEN MONITORING SYS GWM GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK GMS, M 100504

    Patients

    Seq Age Sex Outcome Treatment
    1