BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 24176579 · Received January 26, 2026

    Report

    Report Number
    3001421318-2026-00034
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    December 5, 2025
    Report Date
    January 26, 2026
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    BSK
    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. NR: (B)(4). THE REPORT CONTAINS ALSO THE INVESTIGATION OUTCOME. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. UPON REVIEW OF THE LOGFILES, THE ISSUE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE DEVICE ALARMED WITH TF 5509 AND OTHER SEVERAL TECHNICAL FAULTS ON THE DAY OF THE EVENT. IT IS IMPORTANT TO EMPHASIZE THAT NO PATIENT WAS INVOLVED AT THE TIME THE ALARM OCCURRED. PLEASE SEE BELOW EXTRACT FROM THE LOGFILES. ON (B)(6) 2025, 08:53:11, TF: 9907 , TECH FAULT 9907, (B)(6) 2025, 08:53:10, BODY WT 71.00 KG SETTING 325, (B)(6) 2025, 08:53:10, PATIENT HEIGHT 175 CM SETTING 326, (B)(6) 2025, 08:53:10, TF : 2803 -25227 TECH FAULT 2803, (B)(6) 2025, 08:53:10, TF : 2801 500 TECH FAULT 2801, (B)(6) 2025, 08:53:10, TF : 2804 1 TECH FAULT 2804, (B)(6) 2025, 08:53:10, TF : 2402 7 TECH FAULT 2402, (B)(6) 2025, 08:53:10, TF : 2414 TECH FAULT 2414, (B)(6) 2025, 08:53:10, LOW MINUTE VOLUME ALARMS 5006, (B)(6) 2025, 08:53:10, TF : 2736 354 , TECH FAULT 2736, (B)(6) 2025, 08:53:10, TF : 2736 354 , TECH FAULT 2736, (B)(6) 2025, 08:53:10, TF : 2736 354 , TECH FAULT 2736, (B)(6) 2025, 08:53:10, TF : 2736 354 , TECH FAULT 2736, (B)(6) 2025, 08:53:10 , TF : 2736 354 , TECH FAULT 2736, (B)(6) 2025, 08:53:10 , AUDIO PAUSED OFF SPECIAL 517, (B)(6) 2025, 08:53:10 , AUDIO PAUSED OFF SPECIAL 517, (B)(6) 2025, 08:53:10 , STANDBY OFF SPECIAL 507, (B)(6) 2025, 08:53:10, AMBIENT IRREVERSIBLE SETTING 233, (B)(6) 2025, 08:53:10 , TF : 5509 , TECH FAULT 5509. ACCORDING TO THE SERVICE MANUAL FOR HAMILTON-G5, TF5509 INDICATES THAT THE ERROR SERVO SIGNAL REMAINS ACTIVE FOR 5 SECONDS, INDICATING THAT THE SERVO (INSPIRATORY) VALVE IS NOT FUNCTIONING CORRECTLY. THEREFORE, TO ADDRESS THE ISSUE, THE INSPIRATORY VALVE WAS REPLACED. FOLLOWING REPLACEMENT OF THE COMPONENT, THE ISSUE WAS RESOLVED. HAMILTON MEDICAL CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE GENERATED TF5509 , TF9907 AND TF2414 - NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238243 HAMILTON-G5 HAMILTON-G5 BSK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown