BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION OXYGENATOR

    MDR report key: 438744 · Received January 14, 2003

    Report

    Report Number
    2021836-2003-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2003
    Date of Event
    December 12, 2002
    Report Date
    January 13, 2003
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERFUSIONIST NOTED PINK WATER IN HEATER COOLER LINE. OXYGENATOR WAS CHANGED OUT DURING THE CASE. THERE WAS NO ADVERSE EFFECT UPON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION OXYGENATOR OXYGENATOR DTZ GISH BIOMEDICAL, INC. NA 205200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention