BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-T1

    MDR report key: 18129303 · Received November 14, 2023

    Report

    Report Number
    3001421318-2023-03854
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 2, 2023
    Report Date
    November 18, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002806091
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WERE UPDATED WITH FULL UDI INFORMATION AS REQUESTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: THE VENTILATOR DEVICE ALARMED AND SWITCHED TO SAFETY MODE. THE VENTILATOR DEVICE HAD 'SUCTIONING TOOL' AND 'NBC FILTER' OPTIONS INSTALLED. VARIOUS ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TF341009 (PVENTPRESSURESENSORDEFECT), TF346054 (SAFETYFAILUREDETECTED), TE231036 (PVENTPRESSURESENSORDEFECT), TF 385002 (SAFETYFAILUREDETECTED) AND THE PATIENT ALARMS PA141024(PRESSURELOW), PA141052(PEEPLOW), PA 141005(EXPMINVOLLOW, PA141064 (VTLOWPRIORITYHIGH) THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. VARIOUS LOSS OF PRESSURE ALARMS ARE NOTICED IN THE EVENTS LOGS. THERE IS PATIENT INVOLVEMENT REPORTED. THIS EVENT OCCURRED DURING VENTILATION. THERE WAS NEED FOR MEDICAL INTERVENTION REPORTED BUT NOT FURTHER EXPLAINED. 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: THE VENTILATOR DEVICE ALARMED AND SWITCHED TO SAFETY MODE. THE VENTILATOR DEVICE HAD 'SUCTIONING TOOL' AND 'NBC FILTER' OPTIONS INSTALLED. VARIOUS ALARMS WERE OBSERVABLE BOTH VISUALLY AND THROUGH HEARING. TF341009 (PVENT PRESSURE SENSOR DEFECT), TF346054 (SAFETY FAILURE DETECTED), TE231036 (PVENT PRESSURE SENSOR DEFECT), TF 385002 (SAFETY FAILURE DETECTED) AND THE PATIENT ALARMS PA141024(PRESSURE LOW), PA141052(PEEPLOW), PA 141005(EXPMINVOLLOW, PA141064 (VTLOW PRIORITY HIGH) THE DEVICE LOG FILES WERE PROVIDED TO HAMILTON. VARIOUS LOSS OF PRESSURE ALARMS ARE NOTICED IN THE EVENTS LOGS. THERE IS PATIENT INVOLVEMENT REPORTED. THIS EVENT OCCURRED DURING VENTILATION. THERE WAS NEED FOR MEDICAL INTERVENTION REPORTED BUT NOT FURTHER EXPLAINED. 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
    2203432 HAMILTON-T1 HAMILTON-T1 CBK HAMILTON MEDICAL AG 161009 07630002806091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown