BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 24342700 · Received February 16, 2026

    Report

    Report Number
    3001421318-2026-00066
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 2, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002802208
    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 REF. NO. (B)(4). FOLLOW-UP1: INVESTIGATION OUTCOME. LOGFILES WERE RECEIVED FOR ANALYSIS. ALL RELEVANT DEVICE ACTIONS, INCLUDING SETTINGS ADJUSTMENTS, ALARMS, AND OPERATIONAL EVENTS, ARE APPROPRIATELY DOCUMENTED IN THE LOGFILES. THE DEVICE LOGFILES CONFIRM THE REPORTED ISSUE, HOWEVER, THE RECORDED OCCURRENCE DATE IS 27.01.2026, WHICH DIFFERS FROM THE CUSTOMER REPORTED EVENT DATE OF 04.02.2026. NO PATIENT INVOLVED. ACCORDING TO THE LOGFILE ANALYSIS THE DEVICE ALARMED WITH TECHNICAL FAULTS (TF) 5510 AND 5511, FURTHERMORE, THE CALIBRATION AUTOZERO FAILED. 2026-01-27 23:04:06 AUDIO PAUSED ON SPECIAL 516. 2026-01-27 23:03:49 P-TRIGGER 2.0 -CMH2O SETTING 303. 2026-01-27 23:03:49 TF : 5511 TECH FAULT 5511. 2026-01-27 23:03:49 TF : 5510 TECH FAULT 5510. 2026-01-27 23:03:49 CALIBRATION AUTOZERO FAILED CALIBRATION 614. 2026-01-27 23:03:47 CALIBRATION AUTOZERO FAILED CALIBRATION 614. 2026-01-27 23:03:47 FLOW SENSOR CALIBRATION NEEDED ALARMS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT WAS A DEFECT OF THE SENSOR BOARD 2 AUTOZERO VALVES. TO CORRECT THE ISSUE, A REPLACEMENT SENSOR BOARD 2 WAS SENT TO THE CUSTOMER. DESPITE SEVERAL FOLLOW UP REQUESTS TO CONFIRM WHETHER THE ISSUE WAS RESOLVED, NO FURTHER FEEDBACK HAS BEEN RECEIVED FROM THE END CUSTOMER. AS NO ADDITIONAL INFORMATION WAS RECEIVED, HAMILTON MEDICAL AG CONSIDERS THIS CASE CLOSED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. NR: (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE VENTILATOR HAMILTON-G5 IS EXPERIENCING TECHNICAL FAULTS (TF) 5510 AND 5511. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85727 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown