BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19602144 · Received June 24, 2024

    Report

    Report Number
    3001421318-2024-01499
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 8, 2024
    Report Date
    November 3, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    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: CER (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 21 MAY 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6) 2024, A HAMILTON-T1 (SN (B)(6)), SHOWED A TECHNICAL FAULT 731009 AND TECHNICAL EVENT 231013. THIS TECHNICAL FAULT REFLECTS A POTENTAL FAILURE LEADING TO WRONG O2 CONCENTRATION REGULATION. HMI HAS REQUESTED LOG FILES, CUSTOMER HAS NOT PROVIDED LOG FILES. IF RECEIVED AT A LATER DATE, COMPLAINT FILE WILL BE UPDATED ACCORDINGLY. POTENTIAL ROOT CAUSES THAT COULD BE ASSOCIATED TO THIS ISSUE ARE AS FOLLOW: THE READ VALUES FROM FLOW SENSOR QO2 ARE OUT OF RANGE DUE TO: BAD CONNECTION OR IMPROPER CONNECTION OF THE QO2 SENSOR ON SENSOR SIDE OR CONTROL BOARD SIDE. DEFECTIVE QO2 SENSOR (PART OF THE O2 MIXER ASSEMBLY). POSSIBLE CORRECTION THAT MIGHT BE CONSIDERED ARE AS FOLLOW: CHECK THE QO2 CONNECTOR FOR LOOSE CONNECTORS. CHECK VOLTAGES OF QVENT AND TVENT SENSOR (TEST PINS AND VOLTAGES DESCRIBED IN SERVICE MANUAL. CONSIDER TO REPLACE THE CABLE BETWEEN CONTROL BOARD AND QVENT FLOW SENSOR. CHECK QO2 IN SERVICE SOFTWARE->SYSTEM TEST->O2 MIXER: SET QVENT=15L/MIN, FIO2=61% AND VERIFY QO2 IS 7-8 L/MIN (APPROX 50% FROM QVENT). REPLACE O2 MIXER ASSEMBLY IF PROBLEM REMAINS. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LED 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 21 MAY 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 08 MAY 2024, A HAMILTON-T1 (SN (B)(6)), SHOWED A TECHNICAL FAULT 731009 AND TECHNICAL EVENT 231013. THIS TECHNICAL FAULT REFLECTS A POTENTAL FAILURE LEADING TO WRONG O2 CONCENTRATION REGULATION. HMI HAS REQUESTED LOG FILES; CUSTOMER HAS NOT PROVIDED LOG FILES. IF RECEIVED AT A LATER DATE, COMPLAINT FILE WILL BE UPDATED ACCORDINGLY. POTENTIAL ROOT CAUSES THAT COULD BE ASSOCIATED TO THIS ISSUE ARE AS FOLLOW: THE READ VALUES FROM FLOW SENSOR QO2 ARE OUT OF RANGE DUE TO: -BAD CONNECTION OR IMPROPER CONNECTION OF THE QO2 SENSOR ON SENSOR SIDE OR CONTROL BOARD SIDE -DEFECTIVE QO2 SENSOR (PART OF THE O2 MIXER ASSEMBLY) POSSIBLE CORRECTION THAT MIGHT BE CONSIDERED ARE AS FOLLOW: -CHECK THE QO2 CONNECTOR FOR LOOSE CONNECTORS -CHECK VOLTAGES OF QVENT AND TVENT SENSOR (TEST PINS AND VOLTAGES DESCRIBED IN SERVICE MANUAL -CONSIDER TO REPLACE THE CABLE BETWEEN CONTROL BOARD AND QVENT FLOW SENSOR -CHECK QO2 IN SERVICE SOFTWARE->SYSTEM TEST->O2 MIXER: SET QVENT=15L/MIN, FIO2=61% AND VERIFY QO2 IS 7-8 L/MIN (APPROX 50% FROM QVENT). -REPLACE O2 MIXER ASSEMBLY IF PROBLEM REMAINS. ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE COMPLAINT LED 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
    1104333 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown