BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19316207 · Received May 14, 2024

    Report

    Report Number
    3001421318-2024-01146
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Date of Event
    February 21, 2024
    Report Date
    November 17, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 25 APRIL 2024 IT WAS REPORTED THAT DURING SERVICING HAMILTON T1 VENTILATOR (SN (B)(6), IN TEST-> COMP TEST-> PNEUMATICS 2-> O2 INPUT TEST, WHEN O2 IS CONNECTED TO THE UNIT AND THE TEST IS STARTED, UNIT DISPLAYS: " OXYGEN SUPPLY FAILED" BUT THERE IS A SUPPLY OF O2 TO THE UNIT. OXYGEN SUPPLY FAILED (WITH SW VERSION 2.1.7 OR HIGHER). POTENTIAL ROOT CAUSE ASSOCIATED TO THIS ISSUE COULD BE RELATED TO: HPO GAS SUPPLY OUT OF SPECS OR NOT AVAILABLE, DEFECTIVE PROPORTIONAL VALVE (MIXER ASSEMBLY), DEFECTIVE QO2 FLOW SENSOR (MIXER ASSEMBLY), DEFECTIVE DRIVER BOARD (DRIVER STAGE). ACCORDINGLY, THE FOLLOWING CORRECTION COULD BE CONSIDERED: CHECK O2 INLET FILTER. REPLACE IT IF NECESSARY (PN160497) CHECK HPO SUPPLY IF IN SPECS (2.8 TO 6 BAR , MEDICAL OXYGEN), FLOW: 40 TO 120 L/MIN STPD CHECK O2 MIXER IN SERVICE SOFTWARE TESTS/CALIB- COMP TEST->O2 INPUT, PAGE NO 2112 REPLACE O2 MIXER ASSEMBLY IF TEST FAILS REPLACE DRIVER BOARD IF PROBLEM REMAINS ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 25 APRIL 2024. IT WAS REPORTED THAT DURING SERVICING HAMILTON T1 VENTILATOR (SN (B)(6)), IN TEST-> COMP TEST-> PNEUMATICS 2-> O2 INPUT TEST, WHEN O2 IS CONNECTED TO THE UNIT AND THE TEST IS STARTED, UNIT DISPLAYS: " OXYGEN SUPPLY FAILED" BUT THERE IS A SUPPLY OF O2 TO THE UNIT. OXYGEN SUPPLY FAILED (WITH SW VERSION 2.1.7 OR HIGHER).. POTENTIAL ROOT CAUSE ASSOCIATED TO THIS ISSUE COULD BE RELATED TO: -HPO GAS SUPPLY OUT OF SPECS OR NOT AVAILABLE. -DEFECTIVE PROPORTIONAL VALVE (MIXER ASSEMBLY). -DEFECTIVE QO2 FLOW SENSOR (MIXER ASSEMBLY). -DEFECTIVE DRIVER BOARD (DRIVER STAGE). ACCORDINGLY, THE FOLLOWING CORRECTION COULD BE CONSIDERED: - CHECK O2 INLET FILTER. REPLACE IT IF NECESSARY (PN160497). - CHECK HPO SUPPLY IF IN SPECS (2.8 TO 6 BAR , MEDICAL OXYGEN), FLOW: 40 TO 120 L/MIN STPD. - CHECK O2 MIXER IN SERVICE SOFTWARE ->TESTS/CALIB->COMP TEST->O2 INPUT, PAGE NO 2112. - REPLACE O2 MIXER ASSEMBLY IF TEST FAILS. - REPLACE DRIVER BOARD IF PROBLEM REMAINS. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LEAD TO DEATH, INJURY OR SERIOUS DETERIORATION OF THE HEALTH OF THE PATIENT, USER OR THIRD-PARTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546768 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention