BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5/S1

    MDR report key: 24453614 · Received February 26, 2026

    Report

    Report Number
    3001421318-2026-00092
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 11, 2026
    Report Date
    February 26, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4), (COUNTRY OF ORIGIN: OMAN). CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS DEVICE AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. THE REPORT CONTAINS ALSO THE INVESTIGATION OUTCOME. ACCORDING TO THE LOG FILES PROVIDED FOR ANALYSIS, THE VENTILATOR TRIGGERED "PANEL CONNECTION LOST AND VENTILATOR UNIT CONNECTION" ALARMS. THEREFORE, THE LOGFILES CONFIRMED THE ISSUE. (B)(6) 2026,09:41:17 TF : 2438 TECH FAULT 2438, (B)(6) 2026, 9:39:53 HIGH FREQUENCY ALARMS 4004, (B)(6) 2026, 09:39:47 HIGH MINUTE VOLUME ALARMS 5005, (B)(6) 2026, 09:39:14 HIGH MINUTE VOLUME ALARMS 5005, (B)(6) 2026, 09:39:11 VENTILATOR UNIT CONNECTION LOST ALARMS 5024, (B)(6) 2026, 09:39:09 PANEL CONNECTION LOST ALARMS 4010. TO CORRECT THE ISSUE, THE ESM VU (SOFTWARE VERSION 2.81) AND THE ESM IP (SOFTWARE VERSION 2.81) WERE REPLACED. THE ISSUE WAS REPORTED AS RESOLVED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: "INITIALLY, THE ALARM ¿PANEL CONNECTION LOST¿ APPEARED AND THEN DISAPPEARED WITHOUT BEING SHOWN AGAIN IN THE EVENT LOG. AFTER RECONNECTING THE CABLE, THE ALARM TF9950 APPEARED BRIEFLY AND THEN DISAPPEARED AGAIN." NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519960 HAMILTON-G5/S1 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown