BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 21838159 · Received April 15, 2025

    Report

    Report Number
    3001421318-2025-00525
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    August 15, 2024
    Report Date
    February 17, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    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 CASE NUMBER IS: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OUTCOME: THE VENTILATOR WAS UNEXPECTEDLY SWITCHING MODES DURING USE. THIS BEHAVIOR WAS LINKED TO REPEATED ERROR MESSAGES IN THE LOG, SUCH AS "SENSOR FAILURE MODE VENTILATION INITIATED" AND "EXTERNAL FLOW SENSOR FAILED." THESE MESSAGES APPEARED SEVERAL TIMES OVER A PERIOD FROM APRIL 2024 TO JANUARY 2025, WITH SOME INSTANCES HAPPENING JUST MINUTES APART. THE CAUSE OF THE ISSUE WAS RELATED TO THE FLOW SENSOR, WHICH PLAYS A KEY ROLE IN MEASURING THE PATIENT¿S BREATHING. WHEN THIS SENSOR FAILS, THE VENTILATOR AUTOMATICALLY SWITCHES TO PCV+ MODE TO ENSURE VENTILATION CONTINUES SAFELY. THE FAILURES WERE MOST LIKELY DUE TO PROBLEMS LIKE IMPROPER CONNECTION, KINKED OR BLOCKED TUBING, PRESENCE OF LIQUID INSIDE THE SENSOR, OR FAULTS IN THE SENSOR ITSELF OR IN THE RELATED PRESSURE SENSOR ASSEMBLY. THE DEFECTIVE PRESSURE SENSOR ASSEMBLY HAS NOT ARRIVED YET, SO NO FURTHER ANALYSIS CAN BE TAKEN. EVENTUALLY, BOTH THE PROXIMAL FLOW SENSOR AND THE PRESSURE SENSOR ASSEMBLY WERE EXCHANGED AS PRECAUTIONARY, PREVENTATIVE MEASURES. AFTER THIS CORRECTIVE ACTION, THE VENTILATOR OPERATED NORMALLY AND THE PROBLEM DID NOT RECUR. THIS CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE DEVICE WAS SPONTANEOUSLY CHANGING MODES DURING THE VENTILATION OF A PATIENT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE EVENT LOG SHOWS "SENSOR FAILURE MODE VENTILATION INITIATED" AND THE ERROR LOG SHOWS "INSP CIRCUIT PRESSURE DROP". A COUPLE OF FLOW SENSORS WERE USED. THE ERROR LOG AFTER REPLACING THE PSA STILL SHOWS "INSP CIRCUIT PRESSURE DROP". ALL TESTS HAVE PASSED. THE PATIENT WAS BAGGED AND THE VENTILATOR WAS EXCHANGED. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122938 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown