BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE BRAIN IMC PROBE KIT

    MDR report key: 536027 · Received March 17, 2004

    Report

    Report Number
    9617494-2004-00011
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Report Date
    March 17, 2004
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK GMS, M
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED DIFFICULTY IN PASSING CATHETERS THROUGH BOLT. BOLT AND CATHETERS WERE REMOVED AND REPLACED. THE SAME INCIDENT OCCURRED WITH THE REPLACEMENT KIT. THE TREATING PHYSICIAN WAS VERY FRUSTRATED. THE NURSING STAFF WAS NOT CONFIDENT IN THE PBO2 NUMBERS. THE DEVICE WAS DISCONTINUED TWO DAYS POST INSERTION. THE KIT CONSISTS OF IM3 LOT NUMBER 060803, CC1.SB LOT NUMBER 080903 AND C8.B LOT NUMBER 290903.

    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 SONDENTECHNIK GMS, M * 04204/P

    Patients

    Seq Age Sex Outcome Treatment
    1 *