BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19210958 · Received April 30, 2024

    Report

    Report Number
    3001421318-2024-01051
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    March 25, 2024
    Report Date
    June 13, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS CER (B)(4). INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS (B)(4). INVESTIGATION ONGOING. 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. FOLLOW-UP 2 - ADDITIONAL INFORMATION: FIELDS B4, G6, H2, H3, H6 AND H11 ARE UPDATED. TIGHTNESS TEST FAILED DURING PRE-OPERATIONAL CHECK. 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. 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 WAS REPORTED TO HAMILTON MEDICAL AG: THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE FAILED FOR THE TIGHTNESS (LEAK) AND THE FLOW TESTS. THIS OCCURRENCE WAS NOTICED DURING THE PRE-OPERATIONAL CHECK. A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY (MESSAGE ALERTS: [?]TIGHTNESS TEST FAILS') AND THROUGH HEARING. NO FURTHER DETAILS ABOUT THE ALARMS WERE REPORTED TO HAMILTON MEDICAL AG. THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE NOT PROVIDED TO HAMILTON MEDICAL AG. THERE IS NO PATIENT INVOLVEMENT REPORTED. THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE FAILED FOR THE TIGHTNESS (LEAK) AND THE FLOW TESTS. - THIS OCCURRENCE WAS NOTICED DURING THE PRE-OPERATIONAL CHECK. - A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY (MESSAGE ALERTS: TIGHTNESS TEST FAILS') AND THROUGH HEARING. NO FURTHER DETAILS ABOUT THE ALARMS WERE REPORTED TO HAMILTON MEDICAL AG. - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE NOT PROVIDED TO HAMILTON MEDICAL AG. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS, VENTILATOR DEVICE FAILED FOR THE TIGHTNESS (LEAK) AND THE FLOW TESTS. - THIS OCCURRENCE WAS NOTICED DURING THE PRE-OPERATIONAL CHECK. - A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY (MESSAGE ALERTS: [?]TIGHTNESS TEST FAILS') AND THROUGH HEARING. NO FURTHER DETAILS ABOUT THE ALARMS WERE REPORTED TO HAMILTON MEDICAL AG. - THE DEVICE LOG FILES (SERVICE LOG, ERROR LOG, EVENT LOG) WERE NOT PROVIDED TO HAMILTON MEDICAL AG. - THERE IS NO PATIENT INVOLVEMENT REPORTED. - THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992650 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown