BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 17983873 · Received October 23, 2023

    Report

    Report Number
    3001421318-2023-03583
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    June 30, 2023
    Report Date
    January 26, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE FRONT PANEL HARD KEYS WERE NOT WORKING AND WERE REPLACED.

    Additional Manufacturer Narrative · 0

    THE FRONT PANEL HARD KEYS WERE NOT WORKING AND WERE REPLACED. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY** FIELD D4 WAS NOT UPDATED WITH FULL UDI INFORMATION AS REQUESTED SINCE THE DEVICE WAS MANUFACTURED BEFORE 2015.

    Additional Manufacturer Narrative · 0

    THE FRONT PANEL HARD KEYS WERE NOT WORKING AND WERE REPLACED. ADDITIONAL INFORMATION ADDED IN FOLLOW-UP #2 CER 143019. FIELD B4, G6, H2, H3, H6 AND H11 UPDATED. THE ISSUE WAS DISCOVERED DURING PRE-OPERATIONAL CHECK WITH NO PATIENT INVOLVED. CONSEQUENTLY, THE EVENT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE ROOT CAUSE OF THE EVENT WAS DEEMED TO BE AN ELECTRONIC DEFECT ON IP KEY AND LED BOARD (B)(6). AFTER REPLACING THE IP KEY AND LED BOARD (B)(6) THE DEVICE WAS FOUND TO BE FUNCTIONAL AND WAS RELEASED FOR USE. THE ISSUE IS CONSIDERED A REPORTABLE EVENT BECAUSE IT COULD POTENTIALLY IMPACT PATIENT SAFETY DURING VENTILATION SINCE THE ELECTRONIC DEFECT ON THE IP KEY AND LED BOARD (B)(6) COULD RESULT IN INADEQUATE VENTILATION SUPPORT.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: 02 BOOST BUTTON DOES NOT WORK.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: 02 BOOST BUTTON DOES NOT WORK.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: 02 BOOST BUTTON DOES NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003062 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown