BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIN-O-VAC

    MDR report key: 114788 · Received August 20, 1997

    Report

    Report Number
    2510954-1997-00009
    Event Type
    Injury
    Date Received
    August 20, 1997
    Date of Event
    July 14, 1997
    Report Date
    July 24, 1997
    Manufacturer
    CIG MEDISHIELD
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TWIN-O-VAC VENTURI ACTIVATED SUCTION DEVICE WITH TWO OXYGEN SOURCES TO PROVIDE MULTIPLE THERAPY APPLICATIONS WAS MOUNTED TO AN AIR-SHIELDS INFANT RADIANT WARMER. THE CAREGIVER INTENDING TO ADMINISTER SUCTION INADVERTENTLY CONNECTED TUBING TO AN OXYGEN OUTLET INSTEAD OF THE TWIN-O-VAC SUCTION CONNECTION. PRODUCT LABELING DENOTES OXYGEN VERSUS SUCTION CONNECTIONS, AND OXYGEN AND SUCTION FITTINGS ARE DIFFERENT. INSTRUCTIONS FOR THE USE OF SUCTION ARE CONSIDERED APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIN-O-VAC LOW VENTURI SUCTION DEV. GCX CIG MEDISHIELD NI 521662

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization| L