BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 25147456 · Received May 12, 2026

    Report

    Report Number
    3001421318-2026-00296
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 12, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG:(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. THIS REPORT ALSO CONTAINS THE INVESTIGATION OUTCOME. DURING VENTILATION OF A PATIENT, THE HAMILTON-G5 VENTILATOR'S DISPLAY (LCD) TURNED COMPLETELY WHITE. VENTILATION CONTINUED UNINTERRUPTED. NO PATIENT HARM, ADVERSE HEALTH CONSEQUENCES, OR MEDICAL INTERVENTION WERE REPORTED. ANALYSIS OF THE DEVICE LOG FILES SHOWED NO TECHNICAL FAULTS (TFS) RECORDED. THE REPORTED EVENT DATE APRIL 14, 2026 COULD NOT BE CONFIRMED IN THE DEVICE LOG FILES, AS THE DEVICE WAS POWERED OFF ON (B)(6) 2026 AT 19:54:15, AND NO ACTIVITY WAS RECORDED THEREAFTER. (B)(6) 2026 07:11:00 POWER-ON (B)(6) 2026 POWER 1. (B)(6) 2026 07:11:00 O2 SENSOR CALIBRATION NEEDED ALARMS 3003. (B)(6) 2026 19:54:15 HUMIDIFIER OFF SPECIAL 547. (B)(6) 2026 19:54:15 POWER-OFF (B)(6) 2026 POWER 3. (B)(6) 2026 19:15:22 STANDBY ON SPECIAL 506. (B)(6) 2026 19:15:22 NEBULIZER OFF SPECIAL 501. (B)(6) 2026 19:15:20 SCREEN LOCK OFF SPECIAL 519. (B)(6) 2026 17:55:59 DISCONNECTION ON PATIENT SIDE ALARMS 5010. 2026-04-13 17:22:13 SCREEN LOCK ON SPECIAL 518. ON (B)(6) 2026, NORMAL VENTILATION OPERATION WAS DOCUMENTED WITHOUT ANY TFS OR AMBIENT MODE ENTRIES. BASED ON THE AVAILABLE DATA, THE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, AFTER REPLACEMENT OF THE IP ESM (INTERACTION PANEL ELECTRONIC SYSTEM MODULE), THE ISSUE WAS RESOLVED AND NORMAL DEVICE PERFORMANCE WAS RESTORED. THE CASE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO HAMILTON MEDICAL AG THAT: "AFTER START VENTILATION SCREEN WAS WHITENING . VENTILATION WAS CONTINUING. AFTER SEVERAL MINUTES WAS SCREEN RIGHT AGAIN. VENTILATION CONTINUING WITHOUT INTERRUPT. ACCORDING NURSES THIS SITUATION HAPPENED DURING CLINICAL CASE , ALARM DIDN´T OCCURE." NO PATIENT HARM, SERIOUS DETERIORATION, OR NEED FOR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174208 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1