BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LICOX COMPLETE BRAIN IMC-PROBE KIT

    MDR report key: 386966 · Received April 4, 2002

    Report

    Report Number
    9617494-2002-00006
    Event Type
    Malfunction
    Date Received
    April 4, 2002
    Report Date
    April 4, 2002
    Manufacturer
    GMS-GESSELLSCHAFT FUR MEDIZINISCHE
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY COMPLAINED AFTER INSERTION OF THE DEVICE, THE NUMBERS WERE NORMAL. WHEN THE EEG LEADS WERE REPLACED, THE NUMBERS WERE ERRATIC. IT IS UNCLEAR FROM THE REPORTED INFO IF THE ERRATIC NUMBERS REPRESENTED THE OXYGEN READING, TEMPERATURE READING OR ICP READING. IT IS UNK IF THE PT WAS INJURED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LICOX COMPLETE BRAIN IMC-PROBE KIT BRAIN TISSUE OXYGEN MONITORING SYSTEM GWM GMS-GESSELLSCHAFT FUR MEDIZINISCHE * 121101

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention