BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 22920454 · Received August 29, 2025

    Report

    Report Number
    3001421318-2025-00777
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    May 8, 2025
    Report Date
    October 8, 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 COMPLAINT NUMBER: (B)(4). INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1: DEVICE EVALUATION. 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 LOGFILES ANALYSIS SHOW THAT THE DEVICE ALARMED WITH TF5506, 5505 AND 5502 ON MAY 8TH, 2025. ON (B)(6) 2025 10:17:29 TF : 5506 TECH FAULT 5506, ON (B)(6) 2025 10:17:26 LOW TIDAL VOLUME ALARMS 4005, ON (B)(6) 2025, 10:17:26 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6) 2025, 10:17:26 TF : 5502 TECH FAULT 5502, ON (B)(6)2025, 10:17:24 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6)2025, 10:17:24 TF : 5505 TECH FAULT 5505, ON (B)(6)2025, 10:17:18 OXYGEN SUPPLY FAILED SUPPLY 5016, ON (B)(6)2025, 10:17:17 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6)2025, 10:17:17 TF : 5506 TECH FAULT 5506, ON (B)(6)2025, 10:17:16 LOW MINUTE VOLUME ALARMS 5006, ON (B)(6)2025, 10:17:14 LOW TIDAL VOLUME ALARMS 4005, ON (B)(6)2025, 10:17:14 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6)2025, 10:17:14 TF : 5502 TECH FAULT 5502, ON (B)(6)2025, 10:17:12 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6)2025, 10:17:12 TF : 5505 TECH FAULT 5505, ON (B)(6)2025 ,10:17:00 OXYGEN SUPPLY FAILED SUPPLY 5016, ON (B)(6)2025, 10:16:59 LOW MINUTE VOLUME ALARMS 5006, ON (B)(6)2025, 10:16:59 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6)2025, 10:16:59 TF : 5506 TECH FAULT 5506, ON (B)(6)2025 , 10:16:56 LOW TIDAL VOLUME ALARMS 4005, ON (B)(6)2025, 10:16:56 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6)2025, 10:16:56 TF : 5502 TECH FAULT 5502, ON (B)(6)2025, 10:16:54 AUDIO PAUSED OFF SPECIAL 517, ON (B)(6)2025, 10:16:54 TF : 5505 TECH FAULT 5505, ON (B)(6)2025, 10:16:43 OXYGEN 100 % SETTING 302. ACCORDING TO THE SERVICE MANAL FOR HAMILTON-G5 THE RESPECTIVE TF'S INDICATE THE FOLLOWING: TF5502: POWER SUPPLY SIGNAL OUT OF RANGE (-15/ +15V ± 10%) FOR 1 SECOND. TF5505: TF 5505: TANK PRESSURE ABOVE 550 MBAR FOR 50 MS, INDICATING THAT A MIXER VALVE IS LEAKING OR THE TANK OVERPRESSURE VALVE IS DEFECTIVE. TF 5506: ERROR P TANK SIGNAL ON THE SERVO BOARD REMAINS ACTIVE FOR 5 SECONDS AND THE TANK PRESSURE IS TOO HIGH, INDICATING THAT A MIXER VALVE IS LEAKING. UPON INSPECTION, IT WAS DETERMINED THAT THE ROOT CAUSE WAS A STUCK TANK OVER PRESSURE RELIEF VALVE SPRING . THE TANK OVERPRESSURE RELIEF VALVE WAS RECONNECTED, AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF- 5505, 5502, 5506. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222423 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown