BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 23776147 · Received December 11, 2025

    Report

    Report Number
    3001421318-2025-00964
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 11, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    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). CREATION OF UDI WAS NOT A REQUIREMENT AT THE TIME OF MANUFACTURING OF THIS DEVICE AND HAD NOT YET BEEN IMPLEMENTED IN PRODUCTION. THE REPORT CONTAINS ALSO THE INVESTIGATION OUTCOME. THE MANUFACTURER HAS RECEIVED THE LOGFILES FOR ANALYSIS. THE PROVIDED LOGFILES CONFIRM THE REPORTED ISSUE AT THE DATE OF THE EVENT. (B)(6) 2025 14:29:59 TF: 9612 TECH FAULT 9612 (B)(6) 2025 14:29:54 O2 ENRICHMENT 79 % SETTING 373 (B)(6) 2025 14:29:54 NEBULIZER DURATION 30 MIN SETTING 351 (B)(6) 2025 14:29:54 NEBULIZER SYNCHRONISATION INSPIRATION SETTING 350 (B)(6) 2025 14:29:54 NEBULIZER AEROGEN SETTING 349 (B)(6) 2025 14:29:53 22: EVENT LOG & TECHNICAL STATUS TEST MODE 900 (B)(6) 2025 14:29:50 NEBULIZER OFF SPECIAL 501 (B)(6) 2025 14:29:50 FIO2 MANUAL: ON SETTING 338 (B)(6) 2025 14:29:50 PEEP MANUAL: ON SETTING 337 (B)(6) 2025 14:29:50 %MV MANUAL: ON SETTING 336 (B)(6) 2025 14:29:50 IPP VERS: 02.91C DEVICE 802 (B)(6) 2025 14:29:50 VRC VERSION: 02.90N DEVICE 801 (B)(6) 2025 14:29:50 VUP VERSION: 02.91C DEVICE 800 (B)(6) 2025 14:29:50 TF: 1406 1102 TECH FAULT 1406 (B)(6) 2025 14:29:40 TF: 1629 1857 TECH FAULT 1629 (B)(6) 2025 14:29:39 TF: 1406 1102 TECH FAULT 1406 (B)(6) 2025 14:29:39 INTELLICUFF MODE OFF SPECIAL 535 (B)(6) 2025 14:29:39 STANDBY ON SPECIAL 506 (B)(6) 2025 14:29:39 NEBULIZER OFF SPECIAL 501 (B)(6) 2025 14:29:38 TF: 2736 354 TECH FAULT 2736 (B)(6) 2025 14:29:38 TF: 2736 354 TECH FAULT 2736 (B)(6) 2025 14:29:38 TF: 2736 354 TECH FAULT 2736 (B)(6) 2025 14:29:38 TF: 2736 354 TECH FAULT 2736 (B)(6) 2025 14:29:38 TF: 2736 354 TECH FAULT 2736 (B)(6) 2025 14:29:38 TF: 1629 1857 TECH FAULT 1629 (B)(6) 2025 14:29:38 TF: 9612 TECH FAULT 9612. THE ISSUE WITH TF9612 WAS RESOLVED FOLLOWING THE REPLACEMENT OF THE VU MOTHERBOARD. FOLLOWING THIS, A SW UPDATE WAS NOT POSSIBLE AND THEREFORE A COMMUNICATION PROBLEM WAS DESCRIBED AS WELL: DEVICE WILL POWER ON BUT WILL NOT UPGRADE OR DOWNGRADE. THIS WAS RESOLVED WITH A REPLACEMENT OF THE VU ESM. HAMILTON MEDICAL CONSIDERS THIS CASE AS CLOSED.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: QUOTATION FROM THE REPORTER: "REPLACED MAIN BOARD DUE TO TF9612. DEVICE WILL POWER ON BUT WILL NOT UPGRADE OR DOWNGRADE. NO COMMUNICATION BETWEEN VENT AND SCREEN." NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603199 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown