BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23107354 · Received September 22, 2025

    Report

    Report Number
    3001421318-2025-00813
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 24, 2025
    Report Date
    September 22, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). THE REPORT CONTAINS ALSO 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 PANEL CONNECTION LOST ALARMS. 2025-08-24 11:35:02 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:34:52 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:24:47 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:24:37 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:22:46 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:22:36 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:15:31 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:15:21 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:08:54 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 11:08:45 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 10:50:59 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 10:50:49 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 10:45:21 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 10:45:11 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 10:41:04 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 10:40:54 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 10:39:46 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 10:39:37 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 05:44:30 PANEL CONNECTION LOST ALARMS 4010 2025-08-24 03:33:43 LOW TIDAL VOLUME ALARMS 4005 2025-08-24 03:30:48 LOW TIDAL VOLUME ALARMS 4005 2025-08-24 03:30:41 LOW TIDAL VOLUME ALARMS 4005 (B)(6) 2025 23:07:29 O2 ENRICHMENT SPECIAL 512 THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE VU MOTHERBOARD , WHICH WAS SUBSEQUENTLY REPLACED. FOLLOWING THE REPLACEMENT, THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: THE DEVICE ALARMED WITH PANEL CONNECTION LOST ALARM. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026439 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown