BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23401941 · Received October 28, 2025

    Report

    Report Number
    3001421318-2025-00875
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 15, 2025
    Report Date
    November 28, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    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) INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). FOLLOW-UP 1: INVESTIGATION OUTCOME. AFTER STARTUP, THE DEVICE GENERATED AN AUDIBLE HIGH-PRIORITY SOUND AND A VISUAL ALARM WITH THE TF9907. IN CALIBRATION MODE, NO FLOW IS DELIVERED DURING THE INSPIRATORY VALVE CALIBRATION. NO PATIENT INVOLVED AS PER PROVIDED INFORMATION. HAMILTON MEDICAL AG RECEIVED THE DEVICE LOGFILES FOR ANALYSIS. THE LOG REVIEW SHOWED THAT THE TECHNICAL FAULT 9907 WAS RECORDED ON (B)(6) 2025, AND NOT ON THE REPORTED EVENT DATE (SEPTEMBER 15, 2025). ON (B)(6) 2025 17:35:46 POWER-OFF ON (B)(6) 2025 POWER 3. ON (B)(6) 2025 17:34:50 TF: 2803 -24647 TECH FAULT 2803. ON (B)(6) 2025 17:34:50 TF: 2801 492 TECH FAULT 2801. ON (B)(6) 2025 17:34:50 TF: 2804 2 TECH FAULT 2804. ON (B)(6) 2025 17:34:50 TF: 9907 TECH FAULT 9907. ON (B)(6) 2025 17:34:49 TF: 2803 -24648 TECH FAULT 2803. ON (B)(6) 2025 17:34:49 TF: 2801 504 TECH FAULT 2801. ON (B)(6) 2025 17:34:49 TF: 2804 1 TECH FAULT 2804. ON (B)(6) 2025 17:34:49 TF: 2402 7 TECH FAULT 2402. ON (B)(6) 2025 17:34:49 TF: 2414 TECH FAULT 2414. ON (B)(6) 2025 17:34:49 AUDIO PAUSED OFF SPECIAL 517. ON (B)(6) 2025 17:34:49 AUDIO PAUSED OFF SPECIAL 517. ON (B)(6) 2025 17:34:49 AMBIENT IRREVERSIBLE SETTING 233. ON (B)(6) 2025 17:34:49 TF: 5509 TECH FAULT 5509. THE ROOT CAUSE WAS IDENTIFIED AS A DEFECTIVE INSPIRATORY VALVE. FOLLOWING REPLACEMENT OF THE COMPONENT, THE DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: AFTER STARTUP, THE DEVICE GENERATED AN AUDIBLE HIGH-PRIORITY SOUND AND A VISUAL ALARM WITH THE TF9907. IN CALIBRATION MODE, NO FLOW IS DELIVERED DURING THE INSPIRATORY VALVE CALIBRATION. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420084 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown