BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19602190 · Received June 24, 2024

    Report

    Report Number
    3001421318-2024-01500
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    April 17, 2024
    Report Date
    October 23, 2024
    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: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.

    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: ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #2 (B)(4). FIELD UPDATED. DEVICE ALARMS WITH (RELEASE VALVE DEFECTIVE) 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 21 MAY 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON 08 MAY 2024, A HAMILTON-T1 (SN (B)(6)), SHOWED AN ERROR MESSAGE ALSO FAILS THE LEAK TEST. IGHTNESS TEST FAILS (RELEASE VALVE DEFECTIVE) DUE TO LEAKY OR DEFECTIVE OBSTRUCTION VALVE (2ND GEN HW). AS PER PRELIMINARY INVESTIGATION PERFORMED AFFECTED COMPONENT IS OBSTRUCTION VALVE. TIGHTNESS TEST FAILS. RELEASE VALVE DEFECTIVE IS DISPLAYED OBSTRUCTION VALVE TEST FAILS. POTENTIAL ROOT CAUSES THAT COULD BE ASSOCIATED TO THIS ISSUE ARE AS FOLLOW: LEAKY OR DEFECTIVE OBSTRUCTION VALVE (MEMBRANE IS STUCK). MESSAGE RELEASE VALVE DEFECTIVE APPEARS AFTER SW UPDATE TO 2.2.0. POSSIBLE CORRECTION THAT MIGHT BE CONSIDERED ARE AS FOLLOW: 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 21 MAY 2024 IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6) 2024, A HAMILTON-T1 (SN (B)(6)), SHOWED AN ERROR MESSAGE ALSO FAILS THE LEAK TEST. IGHTNESS TEST FAILS (RELEASE VALVE DEFECTIVE) DUE TO LEAKY OR DEFECTIVE OBSTRUCTION VALVE (2ND GEN HW). AS PER PRELIMINARY INVESTIGATION PERFORMED AFFECTED COMPONENT IS OBSTRUCTION VALVE. TIGHTNESS TEST FAILS. RELEASE VALVE DEFECTIVE IS DISPLAYED OBSTRUCTION VALVE TEST FAILS. POTENTIAL ROOT CAUSES THAT COULD BE ASSOCIATED TO THIS ISSUE ARE AS FOLLOW: LEAKY OR DEFECTIVE OBSTRUCTION VALVE (MEMBRANE IS STUCK) MESSAGE RELEASE VALVE DEFECTIVE APPEARS AFTER SW UPDATE TO 2.2.0 POSSIBLE CORRECTION THAT MIGHT BE CONSIDERED ARE AS FOLLOW: 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 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 (B)(6) 2024. IT WAS REPORTED BY HAMILTON MEDICAL INC, THAT ON (B)(6) 2024, A HAMILTON-T1 (SN (B)(6), SHOWED AN ERROR MESSAGE ALSO FAILS THE LEAK TEST. IGHTNESS TEST FAILS (RELEASE VALVE DEFECTIVE) DUE TO LEAKY OR DEFECTIVE OBSTRUCTION VALVE (2ND GEN HW). AS PER PRELIMINARY INVESTIGATION PERFORMED AFFECTED COMPONENT IS OBSTRUCTION VALVE. TIGHTNESS TEST FAILS. RELEASE VALVE DEFECTIVE IS DISPLAYED OBSTRUCTION VALVE TEST FAILS. POTENTIAL ROOT CAUSES THAT COULD BE ASSOCIATED TO THIS ISSUE ARE AS FOLLOW: LEAKY OR DEFECTIVE OBSTRUCTION VALVE (MEMBRANE IS STUCK) MESSAGE RELEASE VALVE DEFECTIVE APPEARS AFTER SW UPDATE TO 2.2.0. POSSIBLE CORRECTION THAT MIGHT BE CONSIDERED ARE AS FOLLOW: 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
    1103365 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown