BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-VAC MANUAL ASPIRATOR

    MDR report key: 280951 · Received June 8, 2000

    Report

    Report Number
    2425852-2000-00001
    Event Type
    Injury
    Date Received
    June 8, 2000
    Date of Event
    May 5, 2000
    Report Date
    May 9, 2000
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    BTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHILE SUCTIONING A CARDIAC ARREST PT IN PREPARATION TO INTUBATE, THE VVAC LEAKED FLUID ONTO THE RESCUER'S FACE, RIGHT EYE AND LIPS. THE RESCUER WAS GLOVED AND KNEELING NEXT TO THE PRONE PT. THE VVAC WAS HELD VERICALLY DURING USE. THE RESCUER NOTED THE BLACK FOAM DID NOT COVER THE WHOLE EXHAUST VALVE. THE RESCUER BELIEVES THE FLUID IS SUPPOSED TO LEAVE THE CARTRIDGE WHEN FULL TO ALLOW FOR FURTHER SUCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-VAC MANUAL ASPIRATOR MANUAL ASPIRATOR BTA LAERDAL MEDICAL CORP. V-VAC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN