BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 19220693 · Received May 1, 2024

    Report

    Report Number
    3001421318-2024-01066
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 20, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002801850
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 (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. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H11

    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 ALARMED. - THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. HAMILTON MEDICAL AG DIDN'T RECEIVE ANY FURTHER INFORMATION ON THIS. - A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY (ERROR CODE) AND THROUGH HEARING. TE 231008 (O2 VALVE LEAK). - THE DEVICE LOG FILES (SERVICE LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG EXCEPT OF THE ERROR LOG FILE. - THIS MALFUNCTIONING WAS REPRODUCIBLE. - THERE IS PATIENT INVOLVEMENT REPORTED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION BUT WAS NOT FURTHER SPECIFIED NOR EXPLAINED. - 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 ALARMED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION. HAMILTON MEDICAL AG DIDN'T RECEIVE ANY FURTHER INFORMATION ON THIS. A CONTINUOUS ALARM WAS OBSERVABLE BOTH VISUALLY (ERROR CODE) AND THROUGH HEARING. TE 231008 (O2 VALVE LEAK). THE DEVICE LOG FILES (SERVICE LOG, EVENT LOG) WERE PROVIDED TO HAMILTON MEDICAL AG EXCEPT OF THE ERROR LOG FILE. THIS MALFUNCTIONING WAS REPRODUCIBLE. THERE IS PATIENT INVOLVEMENT REPORTED. THIS OCCURRENCE WAS NOTICED DURING PATIENT VENTILATION BUT WAS NOT FURTHER SPECIFIED NOR EXPLAINED. 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
    172455 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161006 07630002801850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown