BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 17245978 · Received July 3, 2023

    Report

    Report Number
    3001421318-2023-02530
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 17, 2023
    Report Date
    August 6, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION FROM THE PARTNER: PER BIOMED, DURING VENTILATION, THE DISPLAY FROZE AND BECAME UNUSABLE, WAVE FORMS STOPPED, BUTTONS NONRESPONSIVE, VENTILATION CONTINUED. SAYS THEY DID GET SOME VISUAL AND AUDIBLE ALARMS. LAST PM WAS DONE IN AUGUST 2022. BIOMED CANNOT DUPLICATE THE ISSUE. THEY MANUALLY BAGGED THE PATIENT WHILE THE VENTILATOR WAS REPLACED WITH ANOTHER VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26463 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown