BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNI 3

    MDR report key: 439484 · Received January 23, 2003

    Report

    Report Number
    1823260-2003-00022
    Event Type
    Death
    Date Received
    January 23, 2003
    Date of Event
    November 17, 2002
    Report Date
    December 6, 2002
    Manufacturer
    AVL GMBH
    Product Code
    CHL
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 0

    PT PRESENTED TO ER POST MOTOR VEHICLE ACCIDENT WITH MULTIPLE LONG BONE FRACTURES. PT TAKEN TO SURGERY FOR IRRIGATION AND DEBRIDEMENT OF OPEN RIGHT TIBIA FRACTURE. TOWARDS END OF PROCEDURE NOTED AS HAVING PERIODS OF HYPOTENSION WITH DECREASED O2 SATURATION. PT TAKEN TO ICU WHERE DIAGNOSIS OF BRAIN DEATH WAS MADE. PT REMAINED ON LIFE SUPPORT UNTIL THEY EXPIRED 9 DAYS LATER. "BRONCHO ALVEOLAR" SENT TO PATHOLOGY AND FINDINGS CONSISTENT WITH FAT EMBOLISM SYNDROME. PO2 TESTED ON PT DATE OF EVENT AT 9:38 AM, PO2 277.9 MMHG AND O2 SATURATION 99.7, AT 14:04 PO2 62.3 MMHG AND O2 SATURATION 91.5% AND AT 17:14 PO2 71.2 MMHG AND O2 SATURATION 93.3%. PHYSICIAN QUESTIONING RELATIONSHIP BETWEEN PO2 AND SO2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 OMNI 3 BLOOD GAS ANALYZER CHL AVL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    0 * Death