BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23508041 · Received November 10, 2025

    Report

    Report Number
    3001421318-2025-00903
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 12, 2025
    Report Date
    December 12, 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 REF. NR: (B)(4). FOLLOW-UP 1: INVESTIGATION OUTCOME. ACCORDING TO THE LOGFILE ANALYSIS, MULTIPLE TECHNICAL FAULTS (TF) APPEARED ON THE SCREEN PRIOR TO THE EVENT. THESE TECHNICAL FAULTS WERE FOLLOWED BY REPEATED ¿DISCONNECTION ON PATIENT SIDE¿ AND LOW MINUTE VOLUME ALARMS, INDICATING POSSIBLE INSTABILITY IN SYSTEM PERFORMANCE. THE SEQUENCE OF EVENTS SUGGESTS THAT THE DEVICE EXPERIENCED SEVERAL TECHNICAL FAULTS (TF: 2450, 1950, 2103, 9950, 9958, 2454, ETC.) WITHIN A SHORT TIMEFRAME, RESULTING IN REPEATED ALARMS RELATED TO VENTILATION PARAMETERS. SUBSEQUENTLY, THE DEVICE WAS POWERED OFF MANUALLY ¿ AS INDICATED BY THE EVENT ¿POWER-OFF¿ ¿ AND NOT DUE TO A POWER FAILURE. THE NEXT EVENT RECORDED IN THE LOGS IS A ¿POWER-ON¿ ON 2025-11-04, CONFIRMING THAT THE SHUTDOWN WAS USER-INITIATED RATHER THAN SYSTEM-TRIGGERED. 2025-11-04 14:46:25 POWER-ON 2025-11-04 POWER 1, 2025-10-12 19:44:25 HUMIDIFIER OFF SPECIAL 547, 2025-10-12 19:44:25 POWER-OFF 2025-10-12 POWER 3, 2025-10-12 19:44:22 AUDIO PAUSED OFF SPECIAL 517, 2025-10-12 19:44:21 AUDIO PAUSED ON SPECIAL 516, 2025-10-12 19:44:18 AUDIO PAUSED OFF SPECIAL 517, 2025-10-12 19:44:16 AUDIO PAUSED ON SPECIAL 516, 2025-10-12 19:44:16 AUDIO PAUSED OFF SPECIAL 517, 2025-10-12 19:44:15 AUDIO PAUSED ON SPECIAL 516, 2025-10-12 19:44:15 AUDIO PAUSED OFF SPECIAL 517, 2025-10-12 19:44:15 AUDIO PAUSED ON SPECIAL 516, 2025-10-12 19:44:15 AUDIO PAUSED OFF SPECIAL 517, 2025-10-12 19:44:14 AUDIO PAUSED OFF SPECIAL 517, 2025-10-12 19:44:14 AUDIO PAUSED OFF SPECIAL 517, 2025-10-12 19:44:14 AUDIO PAUSED ON SPECIAL 516. 2025-10-12 19:43:43 LOW MINUTE VOLUME ALARMS 5006. 2025-10-12 19:43:41 DISCONNECTION ON PATIENT SIDE ALARMS 5010, 2025-10-12 19:43:40 MAXIMUM LEAK COMPENSATION ALARMS 3030, 2025-10-12 19:43:38 DISCONNECTION ON PATIENT SIDE ALARMS 5010, 2025-10-12 19:43:12 LOW MINUTE VOLUME ALARMS 5006, 2025-10-12 19:43:10 HIGH FREQUENCY ALARMS 4004, 2025-10-12 19:43:09 LOSS OF PEEP ALARMS 4001, 2025-10-12 19:43:08 DISCONNECTION ON PATIENT SIDE ALARMS 5010, 2025-10-12 19:43:07 VOLUME LIMITATION ALARMS 4085, 2025-10-12 19:43:07 TF : 2454 TECH FAULT 2454, 2025-10-12 19:42:39 TF : 9958 TECH FAULT 9958 TF_ WDOG_TOUCH, 2025-10-12 19:42:36 TF : 2103 TECH FAULT 2103 ITF_PTIO_QUEUE_READ, 2025-10-12 19:42:36 TF : 1950 TECH FAULT 1950 TF_ TRI_QUEUE_READ, 2025-10-12 19:42:36 TF : 2103 TECH FAULT 2103 ITF_PTIO_QUEUE_READ, 2025-10-12 19:42:36 TF : 1950 TECH FAULT 1950 ITF_TRI_QUEUE_READ, 2025-10-12 19:42:36 TF : 9950 TECH FAULT 9950 TF_ WDOG_UD, 2025-10-12 19:42:28 TF : 2450 TECH FAULT 2450 ITF_AL_IPP_QUEUE_READ, 2025-10-12 19:42:28 TF : 2450 TECH FAULT 2450 ITF_AL_IPP_QUEUE_READ. THE TECHNICIAN REPLACED THE COMMUNICATION CABLE BETWEEN THE VENTILATION UNIT AND THE INTERACTION PANEL, AS WELL AS THE INTERACTION PANEL EMBEDDED SYSTEM MODULE (IP ESM). AFTER THESE COMPONENTS WERE REPLACED, THE DEVICE OPERATED AS INTENDED.

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG REF. (B)(4. INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: "SCREEN FROZE WHILE ON PATIENT, VENTILATION STOPPED" NO HARM TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: "SCREEN FROZE WHILE ON PATIENT, VENTILATION STOPPED" NO HARM TO THE PATIENT WAS REPORTED. CURRENTLY, THE EVENT IS UNDER INVESTIGATION TO VERIFY THE REPORTED ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848364 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002 07630002802208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown