BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 2071507 · Received April 14, 2011

    Report

    Report Number
    2071507
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    February 16, 2011
    Report Date
    April 14, 2011
    Manufacturer
    HAMILTON MEDICAL INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR WAS OPERATING NORMALLY WHEN IT SUDDENLY INDICATED A RED ALARM AND ERROR CODE "TF942". VENTILATOR WAS REPLACED WITH ANOTHER UNIT.======================MANUFACTURER RESPONSE FOR PATIENT VENTILATOR, G5======================MANUFACTURER'S AGENT REPAIRED VENTILATOR ONSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON-G5 VENTILATOR, CONTINUOUS, FACILITY USE CBK HAMILTON MEDICAL INC. G5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *