BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21661199 · Received March 21, 2025

    Report

    Report Number
    3001421318-2025-00452
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 13, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: IT WAS REPORTED THAT THE DEVICE ALARMED WITH THE TECHNICAL FAULTS 444004 (VOLTAGE OUT OF TOLERANCE), 785003, 446029, 485001 AND SWITCHED TO AMBIENT MODE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. HAMILTON MEDICAL INC. HAS REQUESTED FURTHER INFORMATION. HOWEVER, NO FURTHER INFORMATION WAS RECEIVED. HAMILTON MEDICAL INC. SENT A NEW CONTROL BOARD (MSP161502) TO BE REPLACED BY THE CUSTOMER. THERE WAS NO RESPONSE FROM THE CUSTOMER AFTER THREE REQUESTS FOR ADDITIONAL INFORMATION IF REPLACING IT RESOLVED THE ISSUE. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    THE VENTILATOR DEVICE ALERTED FOR VARIOUS TECHNICAL FAULTS. TF 785003 (PM CHANNEL OBSERVATION FAILED), TF 446029 (AMBIENT FAILURE DETECTED), TE 444004 (VOLTAGE OUT OF TOLERANCE), TE 485001 (AMBIENT FAILURE DETECTED) AND SWITCHED TO AMBIENT MODE. THERE IS NO PATIENT INVOLVEMENT REPORTED. THE DATA LOG FILES WERE NOT PROVIDED TO HAMILTON MEDICAL AG. WORST CASE, AMBIENT MODE CAN LED TO A STATE OF SHORTAGE OF OXYGEN FOR THE PATIENT WHAT MAKES THIS CASE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082005 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown