BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 22010979 · Received May 13, 2025

    Report

    Report Number
    3001421318-2025-00600
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 13, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813532
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4).3 COMBINED REPORT. MEASURES TAKEN: THE DRIVER BOARD (PN MSP161500) AND THE POWER SUPPLY (PN MSP396232) WERE REPLACED. THE VENTILATOR DEVICE PASSED THE SERVICE SOFTWARE TESTS SUCCESSFULLY AND IS PUT BACK IN SERVICE.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "DURING PATIENT VENTILATION THE VENTILATOR SIMPLY STOPPED WORKING. SCREEN WENT BLANK, IT WAS AS IF IT HAD JUST SWITCHED OFF. VENT POWERED ON AGAIN AND BEGAN ATTEMPTING TO VENTILATE (OBVS NOT ATTACHED TO PATIENT). SCREEN WAS ILLUMINATED WITH A COMPLETELY BLANK WHITE SCREEN AND ALARM WAS SOUNDING. UNABLE TO SWITCH OFF. ONLY OPTION WAS TO LEAVE TO RUN OUT OF BATTERY. WHEN SWITCHED ON AGAIN APPEARED TO BE FUNCTIONING NORMALLY AGAIN (ALTHOUGH UNTESTED ETC)¿. THE REPORTED ISSUE DID NOT RESULT IN ANY PATIENT HARM. THERE IS NO MEDICAL INTERVENTION, NOR A DELAY OF TREATMENT REPORTED. THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON MEDICAL. THE DEVICE LOG FILES DON¿T COVER THE REPORTED EVENT DATE 23-APR-2025. INSTEAD ON DATE (B)(6) 2025 VARIOUS AMBIENT AND BATTERY RELATED ALERTS WERE LOGGED. THEREFORE, A CHECKING WITH THE REPORTER IS INDICATED. THE VENTILATOR DEVICE MODEL HAMILTON-T1 IS DESIGNED FOR USE DURING PATIENT TRANSPORT. DUE TO THE REPORTED ISSUE AND THE INDICATIONS FOUND IN THE LOGFILE, AN IMPACT ON THE PATIENT HEALTH CANNOT BE EXCLUDED. THEREFORE, THIS CASE WAS ASSESSED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031938 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 1610060 07630002813532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown