BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI 9

    MDR report key: 391232 · Received April 29, 2002

    Report

    Report Number
    1823260-2002-00121
    Event Type
    Injury
    Date Received
    April 29, 2002
    Date of Event
    July 23, 2001
    Report Date
    April 25, 2002
    Manufacturer
    AVL GMBH
    Product Code
    CEM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRITICAL CARE ANALYZER PRODUCED QUESTIONABLE MEASURED HCT RESULT ON SURGERY PATIENT. SURGERY DELAYED. PATIENT RECEIVED TWO UNITS PACKED RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNI 9 MODULAR CRITICAL CARE ANALYZER CEM AVL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention