BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON MEDICAL VENTILATOR

    MDR report key: 269636 · Received March 14, 2000

    Report

    Report Number
    MW1018412
    Event Type
    Injury
    Date Received
    March 14, 2000
    Date of Event
    March 12, 2000
    Report Date
    March 13, 2000
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH BRAIN ANEURYSM AND BRAIN ANEURYSM CLIPPING. WHILE ON VENTILATOR, VENTILATOR FAILED. PT HAD TO BE REMOVED FROM VENTILATOR AND BAGGED BY AMBU BAG. PT'S BP ELEVATED TO 300. NO OTHER EVENTS NOTED. END TIDAL VOLUME REGISTERED TO 60.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON MEDICAL VENTILATOR VENTILATOR CBK HAMILTON MEDICAL, INC. HAMILTON VEOLAR "TUB" TYPE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R