BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 24739277 · Received March 31, 2026

    Report

    Report Number
    3001421318-2026-00174
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 18, 2026
    Report Date
    March 31, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AGS REFERENCE: (B)(4); HAMILTON MEDICAL AGS CONCLUSION: INVESTIGATION IS ONGOING, NO HAMILTON-T1 SERIAL NUMBER WAS AVAILABLE. THE REPORTED ISSUE CONCERNED THE MOUNTING BRACKET WITH PRODUCT NUMBER 161146. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION (QUOTATION OF COMPLAINANT): "THE MOUNTING BRACKET FOR THE HAMILTON T 1 LOOSENS WHILST THE VEHICLE IS IN MOTION. THIS COULD RESULT IN THE VENTILATOR BECOMING UNLOCKED AND BEING UNSECURED IN THE EVENT OF AN ACCIDENT. WE HAVE IDENTIFIED THE RETAINING SCREWS THAT SECURE THE LOCKING MECHANISM AS THE CAUSE OF THE FAULT. WE ARE AWARE THAT THE MOUNTING BRACKET IS NOT A MEDICAL DEVICE; HOWEVER, SHOULD THE BRACKET FAIL, THE VENTILATOR IS DIRECTLY AFFECTED, WHICH JEOPARDISES PATIENT SAFETY. WE HAVE INFORMED OUR SERVICE PARTNER OF THIS ISSUE; THE MOUNT WAS REPLACED IMMEDIATELY AND THE AFFECTED MOUNT WAS HANDED OVER TO THE SERVICE PARTNER." NO PATIENT INVOLVEMENT, NO INTERVENTION NECESSARY. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799874 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG N/A - NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown