BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LICOX OXYGEN MICRO-PROBE

    MDR report key: 537540 · Received March 18, 2004

    Report

    Report Number
    9617494-2004-00012
    Event Type
    Malfunction
    Date Received
    March 18, 2004
    Report Date
    March 17, 2004
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDER
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONLY ONE IS EXPECTED TO BE RETURNED THE OTHER THREE WERE DISCARDED. THIS DEVICE WAS PART OF IM3.ST KIT. THIS USER FACILITY HAD THEIR REFRIGERATOR BREAK AND WITH THREE IM3.ST KITS IN IT. THE THREE KITS WHICH WERE OUT OF THE REFRIGERATOR FOR 24 HOURS WERE OPENED AND TESTED AT ROOM AIR AND THE OXYGEN VALUES WERE 300 AND DID NOT DROP BELOW 90. THE SALES REP ORDERED A REPLACEMENT FOR THIS ACCOUNT WHICH TOOK TWO DAYS TO ARRIVE AT THE ACCOUNT. WHEN THIS DEVICE WAS USED, THE SAME ISSUE OCCURRED WITH THE OXYGEN VALUES. THE VALUES DID NOT DROP BELOW 90. NONE OF THESE DEVICES WERE USED ON A PT. THESE WERE TESTED PRIOR TO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LICOX OXYGEN MICRO-PROBE LICOX BRAIN TISSUE OXYGEN MONITORING SYS GWM GESELLSCHAFT FUR MEDIZINISCHE SONDER * 131003

    Patients

    Seq Age Sex Outcome Treatment
    1 *