BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI 3

    MDR report key: 413379 · Received August 22, 2002

    Report

    Report Number
    1823260-2002-00261
    Event Type
    Malfunction
    Date Received
    August 22, 2002
    Date of Event
    July 15, 2002
    Report Date
    July 16, 2002
    Manufacturer
    AVL GMBH
    Product Code
    GKR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PATIENT SAMPLE RAN ON SUSPECT DEVICE AND HGB RESULT 4.0 G/DL. RERAN ON DIFFERENT ANALYZER AND 9.0 G/DL. SECOND INSTANCE PATIENT SAMPLE RAN ON SUSPECT DEVICE AND 4.8 G/DL, RERAN ON DIFFERENT ANALZYER AND 8.8 G/DL. NO TREATMENT GIVEN TO PATIENT BASED OFF OF SUSPECT DEVICE READINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *