BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI 3

    MDR report key: 439885 · Received January 23, 2003

    Report

    Report Number
    1823260-2003-00016
    Event Type
    Malfunction
    Date Received
    January 23, 2003
    Date of Event
    December 10, 2002
    Report Date
    December 11, 2002
    Manufacturer
    AVL GMBH
    Product Code
    GKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT TESTED ON SUSPECT ANALYZER AND OBTAINED A PO2 RESULT OF 200 MMHG. ACCOUNT WOULD NOT DIVULGE ANY FURTHER INFORMATION REGARDING PATIENT TREATMENT OR RESULTS OBTAINED. CONTROLS WERE RUN AND WITHIN RANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *