BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23412106 · Received October 29, 2025

    Report

    Report Number
    3001421318-2025-00881
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 11, 2025
    Report Date
    October 29, 2025
    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

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. (B)(4). THE REPORT CONTAINS ALSO THE INVESTIGATION OUTCOME. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. ALL IMPORTANT ACTIONS SUCH AS OPERATOR SETTINGS, ACTIONS AND ALARMS, ETC. ARE DOCUMENTED IN THE LOGFILES. BASED ON THE LOGFILE ANALYSIS, THE CUSTOMER¿S REPORTED ISSUE HAS BEEN CONFIRMED. THE DEVICE GENERATED AN ALARM TF: 5511/TF5510. FURTHERMORE, THE CALIBRATION AUTOZERO FAILED. 2025-10-11 23:23:48 TF : 5511 TECH FAULT 5511 2025-10-11 23:23:48 TF : 5510 TECH FAULT 5510 2025-10-11 23:23:48 CALIBRATION AUTOZERO FAILED CALIBRATION 614 2025-10-11 23:23:47 CALIBRATION AUTOZERO FAILED CALIBRATION 614 2025-10-11 23:23:46 CALIBRATION AUTOZERO FAILED CALIBRATION 614 2025-10-11 23:23:46 CALIBRATION FLOW SENSOR FAILED CALIBRATION 600 2025-10-11 23:23:46 FLOW SENSOR CALIBRATION NEEDED ALARMS 3005 2025-10-11 23:23:07 AUDIO PAUSED ON SPECIAL 516 2025-10-11 23:23:01 INTELLICUFF MODE OFF SPECIAL 535 2025-10-11 23:23:01 STANDBY ON SPECIAL 506 2025-10-11 23:23:01 NEBULIZER OFF SPECIAL 501 2025-10-11 23:22:57 INTELLICUFF MODE OFF SPECIAL 535 2025-10-11 23:22:57 AUDIO PAUSED OFF SPECIAL 517 2025-10-11 23:22:57 AUDIO PAUSED OFF SPECIAL 517 2025-10-11 23:22:57 TF : 5511 TECH FAULT 5511 2025-10-11 23:22:57 TF : 5510 TECH FAULT 5510 2025-10-11 23:22:56 CALIBRATION AUTOZERO FAILED CALIBRATION 614 . TO ADDRESS THE ISSUE (AUTOZERO CALIBRATION FAILED AND TF5510 / TF5511) A REPLACEMENT SENSOR BOARD WAS SENT TO THE END CUSTOMER. ACCORDING TO THE PARTNER, THIS RESOLVED THE PROBLEM. HAMILTON MEDICAL CONSIDERS THIS CASE AS CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF: 5510,5511. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2741500 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown