BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23741018 · Received December 8, 2025

    Report

    Report Number
    3001421318-2025-00952
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    October 11, 2025
    Report Date
    December 8, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). THE REPORT CONTAINS ALSO THE DEVICE EVALUATION. THE MANUFACTURER HAS RECEIVED THE LOGFILES FOR ANALYSIS. ACCORDING TO THE LOGFILES ANALYSIS EXHALATION OBSTRUCTION ALARM WAS RECORDED. 2025-10-15 12:45:51 OPERATING TIME: 8 HOUR(S) 37 MINUTE(S) DEVICE 825. 2025-10-15 12:45:51 OPERATING TIME: 386 DAY(S) DEVICE 826. 2025-10-15 12:45:51 POWER-ON 2025-10-15 POWER 1. 2025-10-11 17:36:45 HUMIDIFIER OFF SPECIAL 547. 2025-10-11 17:36:45 POWER-OFF 2025-10-11 POWER 3. 2025-10-11 17:32:21 STANDBY ON SPECIAL 506. 2025-10-11 17:32:21 NEBULIZER OFF SPECIAL 501. 2025-10-11 17:32:16 EXHALATION OBSTRUCTED ALARMS 5015. 2025-10-11 17:32:09 EXHALATION OBSTRUCTED ALARMS 5015. THE ROOT CAUSE WAS IDENTIFIED AS A¿DEFECTIVE EXPIRATORY VALVE, WHICH WAS SUBSEQUENTLY REPLACED. FOLLOWING THE REPLACEMENT, THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH "EXHALATION OBSTRUCTED". NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143381 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown