BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI 3

    MDR report key: 439897 · Received January 23, 2003

    Report

    Report Number
    1823260-2003-00021
    Event Type
    Malfunction
    Date Received
    January 23, 2003
    Date of Event
    November 4, 2002
    Report Date
    December 6, 2002
    Manufacturer
    AVL GMBH
    Product Code
    CHL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PATIENT TESTED ON SUSPECT ANALYZER AND PO2 RESULT 152.6 MMHG, O2 SATURATION 90% AND DEOXYHB RESULT 9.9%. 6 HOURS LATER TESTED ON SUSPECT ANALYZER AGAIN AND PO2 RESULT 170.8 MMHG, O2 SATURATION 97.4% AND DEOXYHB RESULT 2.6%. PHYSICIAN WAS QUESTIONING RELATIONSHIP BETWEEN PO2 AND SO2 RESULTS. ACCOUNT DID NOT INDICATE ANY TREATMENT HAD BEEN GIVEN TO PATIENT BASED OFF OF RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *