BEUDAMED
    FDA Adverse Event Other Summary report: N

    GALILEO

    MDR report key: 554200 · Received October 28, 2004

    Report

    Report Number
    554200
    Event Type
    Other
    Date Received
    October 28, 2004
    Date of Event
    October 25, 2004
    Report Date
    October 28, 2004
    Manufacturer
    HAMILTON MEDICAL, INC.
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR STARTED TO ALARM WITH A HIGH-PITCHED SOUND. IT WAS NOT DELIVERING ANY BREATHS TO THE PATIENT. THE SCREEN WAS GRAY WITH NO INFORMATION DISPLAYED. THE NURSE WAS IN THE ROOM AT THE TIME AND RESPIRATORY THERAPY RESPONDED IMMEDIATELY AFTER HEARING THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO VENTILATOR CBK HAMILTON MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR