BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LICOX OXYGEN CATHETER MICRO-PROBE

    MDR report key: 455626 · Received April 22, 2003

    Report

    Report Number
    9617494-2003-00009
    Event Type
    Malfunction
    Date Received
    April 22, 2003
    Report Date
    April 21, 2003
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDE
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON TRANSPORTING THE PT FROM THE SCANNER, THE BRAIN OXYGEN CATHETER MALFUNCTIONED. THE OTHER TWO CATHETERS; THE VENTRIX ICP AND THE TEMPERATURE CATHETER FUNCTIONED AS DESIRED. CATHETER NUMBER 115 FROM LOT NUMBER 2000103 WAS USED ON THE PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LICOX OXYGEN CATHETER MICRO-PROBE LICOX BRAIN TISSUE OXYGEN MONITORING SYS GWM GESELLSCHAFT FUR MEDIZINISCHE SONDE * 2000103

    Patients

    Seq Age Sex Outcome Treatment
    1 *