BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE BRAIN IMC-PROBE KIT

    MDR report key: 597332 · Received June 23, 2004

    Report

    Report Number
    9617494-2004-00020
    Event Type
    Malfunction
    Date Received
    June 23, 2004
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED USING LICOX SYSTEM IN THE LAST TWO CASES AND THE IM1. S PROBE WAS INSERTED FOR FIVE DAYS. SUDDENLY THE PROBE STARTED GIVING ZERO READING. THE USER FACILITY THREW OUT AND ONLY HAD ONE TO SEND BACK FROM LOT NUMBER 150304.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE BRAIN IMC-PROBE KIT LICOX BRAIN TISSUE OXYGEN MONITORING SYS GWM GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH * 150304

    Patients

    Seq Age Sex Outcome Treatment
    1 *