BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19640356 · Received June 29, 2024

    Report

    Report Number
    3001421318-2024-01560
    Event Type
    Malfunction
    Date Received
    June 29, 2024
    Date of Event
    May 23, 2024
    Report Date
    May 27, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813532
    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. UPDATED FIELDS: B4, D1, D3, D4, G6, H2, H4, H11.

    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. ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #2 CER 154266. FIELD B4, G6, H2, H3, H6 AND H11 UPDATED. DEVICE ALARMS WITH (RELEASE VALVE DEFECTIVE) DURING PRE OPERATIONAL CHECK AND TIGHTNESS TEST FAILED. NO PATIENT INVOLVED. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE TIGHTNESS TEST IS PERFORMED DURING STARTUP OF THE VENTILATOR TO VERIFY THE INTEGRITY OF THE BREATHING CIRCUIT, ENSURING THERE ARE NO LEAKS THAT COULD COMPROMISE VENTILATION. THE TEST IS DESIGNED TO DETECT LEAKS IN THE VENTILATOR CIRCUIT, INCLUDING TUBING, CONNECTIONS, AND THE PATIENT INTERFACE. IT ENSURES THAT THERE IS NO UNINTENDED GAS LEAKAGE THAT COULD AFFECT VENTILATION PERFORMANCE. THE OPERATOR'S MANUAL SPECIFIES THAT THE PREOPERATIONAL CHECK, WHICH INCLUDES THE TIGHTNESS TEST, MUST ALWAYS BE CONDUCTED PRIOR TO PATIENT USE. BOTH THE TIGHTNESS TEST AND THE COMPENSATORY MECHANISMS FOR MINOR LEAKS ARE DESIGNED TO ENSURE THE VENTILATOR OPERATES SAFELY AND EFFECTIVELY. A FAILED TIGHTNESS TEST OR MINOR LEAK DETECTION DURING VENTILATION DOES NOT INDICATE A MALFUNCTION BUT RATHER TRIGGERS THE VENTILATOR'S SAFETY MECHANISMS TO EITHER ALERT THE OPERATOR OR ADAPT TO THE SITUATION. IN CONCLUSION, A FAILED TIGHTNESS TEST IS NOT A MALFUNCTION AND SHOULD NOT BE VIEWED AS AN IMMEDIATE OR CRITICAL FAILURE. THERE IS NO INFORMATION THAT REASONABLY SUGGEST THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THEREFORE, BASED ON THIS INFORMATION, THE EVENT IS ASSESSED AS NO LONGER REPORTABLE AND THE EVENT CAN BE CLOSED WITH THIS FOLLOW UP REPORT.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED TO HAMILTON MEDICAL AG ON 23 MAY 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 23 MAY 2024 WHEN DOING PRE-OP CHECK, A HAMILTON T1 VENTILATOR (SN (B)(6)) FAILED LEAK TEST AND MESSAGE STATING "RELEASE VALVE INEFFECTIVE". TIGHTNESS TEST FAILS (RELEASE VALVE DEFECTIVE) DUE TO LEAKY OR DEFECTIVE OBSTRUCTION VALVE (2ND GEN HW). ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: - LEAKY OR DEFECTIVE OBSTRUCTION VALVE (MEMBRANE IS STUCK). - MESSAGE RELEASE VALVE DEFECTIVE APPEARS AFTER SW UPDATE TO 2.2.0. THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: -THE MESSAGE "RELEASE VALVE DEFECTIVE" WAS INTRODUCED WITH SW2.2.0 IN CASE THE OBSTRUCTION VALVE DOESN'T OPEN DURING TIGHTNESS TEST. IF THE MESSAGE APPEARS AFTER SW UPDATE TO 2.2.0 OR HIGHER, THE TIGHTNESS TEST NEEDS TO BE PERFORMED SUCCESSFULLY IN ORDER TO RESET THE ALARM. -CHECK IF OBSTRUCTION VALVE IS CONNECTED PROPERLY. -REPLACE CHECK VALVE ASSEMBLY IMPORTANT: AFTER THE REPLACEMENT OF THE CHECK VALVE ASSEMBLY AND START-UP OF THE DEVICE, THE MESSAGE "RELEASE VALVE DEFECTIVE" REMAINS UNTIL THE TIGHTNESS TEST WAS PERFORMED SUCCESSFULLY. 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 23 MAY 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 23 MAY 2024 WHEN DOING PRE-OP CHECK, A HAMILTON T1 VENTILATOR (SN (B)(6)) FAILED LEAK TEST AND MESSAGE STATING "RELEASE VALVE INEFFECTIVE". TIGHTNESS TEST FAILS (RELEASE VALVE DEFECTIVE) DUE TO LEAKY OR DEFECTIVE OBSTRUCTION VALVE (2ND GEN HW). ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: - LEAKY OR DEFECTIVE OBSTRUCTION VALVE (MEMBRANE IS STUCK) - MESSAGE RELEASE VALVE DEFECTIVE APPEARS AFTER SW UPDATE TO 2.2.0 THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: -THE MESSAGE "RELEASE VALVE DEFECTIVE" WAS INTRODUCED WITH SW2.2.0 IN CASE THE OBSTRUCTION VALVE DOESN'T OPEN DURING TIGHTNESS TEST. IF THE MESSAGE APPEARS AFTER SW UPDATE TO 2.2.0 OR HIGHER, THE TIGHTNESS TEST NEEDS TO BE PERFORMED SUCCESSFULLY IN ORDER TO RESET THE ALARM. -CHECK IF OBSTRUCTION VALVE IS CONNECTED PROPERLY. -REPLACE CHECK VALVE ASSEMBLY. IMPORTANT: AFTER THE REPLACEMENT OF THE CHECK VALVE ASSEMBLY AND START-UP OF THE DEVICE, THE MESSAGE "RELEASE VALVE DEFECTIVE" REMAINS UNTIL THE TIGHTNESS TEST WAS PERFORMED SUCCESSFULLY. 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 23 MAY 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 23 MAY 2024 WHEN DOING PRE-OP CHECK, A HAMILTON T1 VENTILATOR (SN (B)(6)) FAILED LEAK TEST AND MESSAGE STATING "RELEASE VALVE INEFFECTIVE". TIGHTNESS TEST FAILS (RELEASE VALVE DEFECTIVE) DUE TO LEAKY OR DEFECTIVE OBSTRUCTION VALVE (2ND GEN HW). ACCORDING TO THE PRELIMINARY INVESTIGATION PERFORMED, POTENTIAL ROOT CAUSE ASSOCIATED TO THE REPORTED ISSUE ARE AS FOLLOW: - LEAKY OR DEFECTIVE OBSTRUCTION VALVE (MEMBRANE IS STUCK). - MESSAGE RELEASE VALVE DEFECTIVE APPEARS AFTER SW UPDATE TO 2.2.0. THE FOLLOWING CORRECTION CAN BE CONSIDERED ACCORDINGLY: -THE MESSAGE "RELEASE VALVE DEFECTIVE" WAS INTRODUCED WITH SW2.2.0 IN CASE THE OBSTRUCTION VALVE DOESN'T OPEN DURING TIGHTNESS TEST. IF THE MESSAGE APPEARS AFTER SW UPDATE TO 2.2.0 OR HIGHER, THE TIGHTNESS TEST NEEDS TO BE PERFORMED SUCCESSFULLY IN ORDER TO RESET THE ALARM. -CHECK IF OBSTRUCTION VALVE IS CONNECTED PROPERLY. -REPLACE CHECK VALVE ASSEMBLY. IMPORTANT: AFTER THE REPLACEMENT OF THE CHECK VALVE ASSEMBLY AND START-UP OF THE DEVICE, THE MESSAGE "RELEASE VALVE DEFECTIVE" REMAINS UNTIL THE TIGHTNESS TEST WAS PERFORMED SUCCESSFULLY. 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
    2174806 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 1610060 07630002813532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown