BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23001842 · Received September 9, 2025

    Report

    Report Number
    3001421318-2025-00789
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 9, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002802208
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). THE REPORT ALSO CONTAINS THE DEVICE EVALUATION. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. UPON REVIEW OF THE LOGFILES, THE ISSUE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE VENTILATOR ISSUED MULTIPLE DISCONNECTION ON VENTILATOR SIDE ALARMS. NO HARM TO THE PATIENT WAS REPORTED. (B)(6) 2025 08:56:06 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. (B)(6) 2025 08:55:50 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. (B)(6) 2025 08:55:20 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. (B)(6) 2025 08:25:32 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. (B)(6) 2025 08:21:02 DISCONNECTION ON VENTILATOR SIDE ALARMS 5011. THE ALARMS WERE CAUSED BY A DEFECTIVE SERVO MODULE. A REPLACEMENT OF THE SERVO MODULE WAS SENT TO THE END CUSTOMER. ACCORDING TO THE PARTNER, THIS RESOLVED THE PROBLEM.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: DURING THE VENTILATION OF A PATIENT, THE VENTILATOR WILL INTERMITTENTLY ALARM DISCONNECTION ON VENTILATOR SIDE AND THE FLOW WAVEFORM WILL DISAPPEAR IN ASV MODE. ALL PRESSURE AND VOLUME MEASUREMENTS CONTINUE TO STAY ACCURATE AND THE VENTILATOR STILL VENTILATES APPROPRIATELY. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066983 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown