BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23070298 · Received September 17, 2025

    Report

    Report Number
    3001421318-2025-00806
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 6, 2025
    Report Date
    December 2, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS DEVICE AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). FOLLOW-UP 1: INVESTIGATION OUTCOME. ACCORDING TO THE INFORMATION RECEIVED, THE DEVICE ALARMED WITH "PANEL CONNECTION LOST", ALONG WITH TECHNICAL FAULTS 9421AND 9907 . HAMILTON MEDICAL AG RECEIVED THE DEVICE LOGFILES FOR ANALYSIS, IN WHICH THE REPORTED ISSUE CAN BE OBSERVED. IN ADDITION TO THIS, OTHER ALARMS WERE ALSO RECORDED IN THE LOGFILE. PLEASE SEE BELOW AN EXTRACT FROM THE LOGFILES: (B)(6) 2025 10:32:53 AMBIENT IRREVERSIBLE SETTING 233. (B)(6) 2025 10:32:53 TF : 2803 3540 TECH FAULT 2803. (B)(6) 2025 10:32:53 TF : 2801 492 TECH FAULT 2801. (B)(6) 2025 10:32:53 TF : 2804 1 TECH FAULT 2804. (B)(6) 2025 10:32:53 TF : 9907 TECH FAULT 9907. (B)(6) 2025 10:32:52 TF : 9421 TECH FAULT 9421. (B)(6) 2025 10:32:52 TF : 2414 TECH FAULT 2414. (B)(6) 2025 10:32:51 AUDIO PAUSED OFF SPECIAL 517. (B)(6) 2025 10:32:51 TF : 2453 TECH FAULT 2453. (B)(6) 2025 10:32:51 PANEL CONNECTION LOST ALARMS 4010. (B)(6) 2025 10:32:51 NEBULIZER OFF SPECIAL 501. (B)(6) 2025 10:32:51 OPTIONS HLI OFF SPECIAL 526. (B)(6) 2025 10:32:51 OXYGEN 45 % SETTING 302. THE "PANEL CONNECTION LOST" ALARM INDICATES THAT COMMUNICATION BETWEEN THE INTERACTION PANEL AND THE VENTILATOR UNIT IS INTERRUPTED. THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE VU ESM BOARD, WHICH WAS SUBSEQUENTLY REPLACED. AFTER THE REPLACEMENT, THE DEVICE OPERATED AS INTENDED AND WAS PUT BACK IN USE.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: DURING VENTILATION, THE ALARMED WITH PANEL CONNECTION LOST AND TFS 9421, 9907. ALTERNATIVE VENTILATION WAS PROVIDED. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598095 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown