BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 595104 · Received July 19, 2004

    Report

    Report Number
    2937708-2004-00005
    Event Type
    Malfunction
    Date Received
    July 19, 2004
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN INTERNAL AUDIT IN JULY 2004 OF THE DHR FOR THIS INSTRUMENT A NOTE INCLUDED IN THE REPAIR PAPERWORK DATED 12/2003 WAS FOUND FROM THE HOSPITAL STATING TAHT "VENT SHUT OFF WHEN ON A PT AND DISPLAYED A TECHNICAL FAULT 5571".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *