BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 22085827 · Received May 27, 2025

    Report

    Report Number
    3001421318-2025-00623
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 27, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG COMPLAINT NUMBER: (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 DEVICE EVALUATION. HAMILTON MEDICAL AG RECEIVED THE LOGFILES OF THE DEVICE FOR ANALYSIS. BASED ON THE ANALYSIS OF THE LOG FILES, THE DEVICE RECORDED A PANEL CONNECTION LOST, HOWEVER THERE IS THE POSSIBILITY THAT THE DEVICE DATE/TIME WAS SET INCORRECT. BELOW IS AN EXTRACT FROM THE LOG FILES FOR REFERENCE: ON (B)(6) 2000 20:00:32 PANEL CONNECTION LOST ALARMS 4010, ON (B)(6) 2021 09:38:55 PANEL CONNECTION LOST ALARMS 4010, ON (B)(6) 20215 09:38:45 PANEL CONNECTION LOST ALARMS 4010. THE "PANEL CONNECTION LOST" ALARM INDICATES THAT COMMUNICATION BETWEEN THE INTERACTION PANEL (IP) AND VENTILATOR UNIT (VU) IS INTERRUPTED. THE EVENT DID NOT OCCUR DURING VENTILATION. NEVERTHELESS, IF SUCH AN EVENT WERE TO OCCUR DURING VENTILATION, THE THERAPY MIGHT BE AFFECTED AND THEREFORE A POTENTIAL DETERIORATION IN THE PATIENT' STATE OF HEALTH CANNOT BE EXCLUDED. THEREFORE, THIS EVENT IS CONSIDERED REPORTABLE. THE SERVICE TECHNICIAN CONDUCTED TROUBLESHOOTING AND IDENTIFIED THE ROOT CAUSE AS A DEFECTIVE VU (VENTILATOR UNIT) ESM. CONSEQUENTLY, THE DEFECTIVE COMPONENT WAS REPLACED. AFTER THE REPLACEMENT, THE DEVICE WORKED AS INTENDED AND PASSED THE TEST SOFTWARE (TSW).

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING DESCRIPTION: AFTER THE UNIT WAS SWITCHED ON, THE DEVICE ALARMED WITH INVALID SERIAL NUMBER AND PANEL CONNECTION LOST. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990914 HAMILTON-G5 HAMILTON-G5 CBK HAMILTON MEDICAL AG 159001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown