BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 22768901 · Received August 11, 2025

    Report

    Report Number
    3001421318-2025-00743
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    June 2, 2025
    Report Date
    December 3, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). FOLLOW-UP 1: 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. THE LOG FILES CONFIRM THE REPORTED ISSUE. 2025-06-02 12:23:29 TF : 5502 TECH FAULT 5502. 2025-06-02 12:23:29 AUDIO PAUSED OFF SPECIAL 517. 2025-06-02 12:23:29 OXYGEN + AIR SUPPLIES FAILED SUPPLY 5017. 2025-06-02 12:23:28 NEBULIZER OFF SPECIAL 501. 2025-06-02 12:23:28 STANDBY ON SPECIAL 506. 2025-06-02 12:23:28 OPERATING TIME: 21 HOUR(S) 0 MINUTE(S) DEVICE 825. 2025-06-02 12:23:28 OPERATING TIME: 737 DAY(S) DEVICE 826. 2025-06-02 12:23:28 POWER-ON 2025-06-02 POWER 1. THE ISSUE (TF5502) WAS TRACED TO A DEFECTIVE VU MOTHERBOARD. THE MOTHERBOARD WAS REPLACED, AND TESTING AFTERWARD CONFIRMED THAT THE PROBLEM IS FULLY RESOLVED. THE UNIT IS NOW OPERATING NORMALLY.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF5502. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035022 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown