BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21975716 · Received May 7, 2025

    Report

    Report Number
    3001421318-2025-00592
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 23, 2025
    Report Date
    February 19, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002813532
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF NR: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: ACCORDING TO THE LOG FILE, THE DEVICE WAS SWITCHED ON AT 00:00:47 ON 23 APRIL 2025 AND STARTED IN SIMV+ MODE AT 00:16:32. AT 00:16:33, THE DEVICE ALREADY TRIGGERED AN ALARM FOR INSPIRATORY VOLUME LIMITATION, DISCONNECTION ON THE PATIENT SIDE AND LOW MINUTE VOLUME. AT 00:17:15, THE DEVICE WAS PUT INTO STANDBY MODE AND RESTARTED IN SIMV+ MODE AT 00:17:37. THIS TIME, THE DEVICE ALSO STARTED TO ALARM AFTER ONLY 2 SECONDS. THERE ARE NO ENTRIES IN THE LOG FILE INDICATING A TECHNICAL EVENT OR TECHNICAL ERROR THAT WOULD SUGGEST A DEFECT IN THE DEVICE. AFTER CHECKING WITH CLINICAL EXPERTS, THE MOST LIKELY CAUSE IS A LEAK, A DISCONNECTION, THE SETTINGS OR THE PATIENT. NO MALFUNCTIONS OR DEFECTS WERE FOUND, WHICH INDICATES A PROBLEM CAUSED BY THE USER. BIOMEDICAL DID NOT PROVIDE ANY LOG FILES AS NO PROBLEMS WERE DETECTED DURING TESTING. IT WAS SUGGESTED THAT TRAINING SHOULD BE PROVIDED ON UNDERSTANDING THE RELEVANT LEAKAGE ALARMS AND TROUBLESHOOTING ON FLOW SENSOR CONTROL SETTINGS. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: QUOTATION FROM THE REPORTER: "ON TRANSFER TO ICU AS THE HOSPITAL STAFFS TRAVELLED THROUGH THE BUMPS ON THE CORRIDOR FLOOR, THE VENTILATOR STARTED FAILING AND STARTED TO MAKE FUNNY NOISES. THE HOSPITAL STAFFS NOTICED THE MONITORING WAVES STARTED TO LOOK LIKE SMALL "SVT" LIKE WAVES AND THE MONITORING NUMBERS STARTED TO DROP. THE HOSPITAL STAFFS IMMEDIATELY STOPPED AND WAITED FOR MACHINE TO POTENTIALLY FIX ITSELF. NIL ANATOMICAL CHANGES OR DETERIORATION HAPPENED AT THIS TIME TO THE PATIENT. AFTER A GOOD 20 SECONDS, THE HOSPITAL STAFFS KEPT TRANSPORTING THE PATIENT TO ICU WARD. AFTER MORE BUMPS ON THE FLOOR, THE SAME THING HAPPENED AGAIN EXCEPT THIS TIME THE PATIENT STARTED TO DESATURATE DOWN TO 92. THE SURGEON AND THE NURSE THEN DISCONNECTED THE VENTILATOR AND STARTED TO MANUALLY VENTILATE THE PATIENT WITH GOOD AFFECT. THE NURSE THEN RAN TO GET HELP FROM THE ICU STAFF. THE HOSPITAL STAFFS STARTED TO KEEP WHEELING THE PATIENT INTO THE POD AND DID SUCCESSFUL HANDOVER AND TRANSFER ONTO THEIR BED." ACCORDING TO THE COMPLAINT DESCRIPTION, NO HARM TO THE PATIENT WAS REPORTED. THERE ARE NO ENTRIES IN THE LOG FILE INDICATING A TECHNICAL EVENT OR TECHNICAL ERROR THAT WOULD SUGGEST A DEFECT IN THE DEVICE. FURTHER INQUIRIES HAVE BEEN SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS ABOUT THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871902 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 1610060 07630002813532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown