BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAMILTON G5 VENTILATOR

    MDR report key: 23349718 · Received October 21, 2025

    Report

    Report Number
    MW5177729
    Event Type
    Other
    Date Received
    October 21, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 17, 2025
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INCIDENT LOCATION: (B)(6) RELATED INCIDENT MATERIAL: STANDARD ISO 19223 FIRST EDITION 2019-07 LUNG VENTILATORS AND RELATED EQUIPMENT - VOCABULARY AND SEMANTICS (B)(6) RESPONSE: "WE DONT FOLLOW THAT STANDARD" (B)(6) WAS PLACED ON A MECHANICAL VENTILATOR, REFERRED TO INITIALLY BY THE MD'S AS A "RESPIRATOR". UPON LOOKING AT THE VENTILATOR, I NOTED THAT SHE WAS PLACED ON A HAMILTON G5 MECHANICAL VENTILATOR. THE HAMILTON G5 VENTILATOR DOES NOT FOLLOW ISO 19223 STANDARDS IN ITS CURRENT FORM BUT AS OF OPERATOR MANUAL 2.9, HAS INTRODUCED THE ISO STANDARD TO ITS NOMENCLATURE IN THE OPERATOR MANUAL. HOWEVER, WHEN IN USAGE, THE VENTILATOR FAILS TO CONFORM TO THE STANDARDS THAT THE FDA HAS IMPLEMENTED THROUGH ISO 19223. THIS HAS CAUSED PATIENT HARM DUE TO THE INABILITY OF THE STAFF TO PROPERLY LABEL THE VENTILATOR MODE ACCORDING TO THE ISO STANDARD AND TRANSLATION GUIDE PROVIDED BY HAMILTON. THE HAMILTON G5 ONLY REQUIRES A SOFTWARE UPDATE TO FIX THIS PROBLEM BUT IT HAS BEEN IGNORED BY THEM BUT ACKNOWLEDGED IN THEIR USER MANUAL. THE MANUFACTURER IS IGNORING A SIMPLE FIX AND THE STAFF ARE ATTEMPTING TO CHART TO AN ARBITRARILY DEFINED MODE CLASSIFICATION SCHEME THAT IS IMPEDING REVIEW OF THEIR CARE PROCESSES. PLEASE REVIEW THIS CASE AND LET ME KNOW WHAT YOU THINK. I BELIEVE A SOFTWARE UPDATE SHOULD BE RELEASED POST HASTE THAT CONFORMS THE MEDICAL DEVICE TO WHAT THE TECHNICIANS PREFER TO CHART "WHICH APPEARED TO BE ACCORDING TO ISO STANDARDS FROM THEIR INITIALLY ENTERED COMMENTS, NOT THE REDONE COMMENTS". THE HOSPITAL SHOULD CONFORM TO FDA STANDARDS INSTEAD OF A RANDOM VENTILATOR MANUFACTURER. CURRENTLY: THE STAFF HAVE GONE ON STRIKE; THERE IS A REGISTRY TAKING CARE OF (B)(6) AND EVERY DAY WE NEED TO ENSURE THAT THE TECHNICIANS ARE FAMILIAR WITH THE G5 AND ITS NOMENCLATURE. WE ARE HAVING PEOPLE FROM (B)(6) AND OTHER STATES CURRENTLY FLYING IN TO HELP TAKE OF (B)(6) WHILE THE STAFF AT (B)(6) ARE ON STRIKE. PLEASE DO NOT DELAY, WE HAVE TO DEAL WITH THIS GOING INTO SUNDAY! THE COMMENTS DEMONSTRATE THE RESPIRATORY THERAPISTS UNDERSTANDING OF WHAT THE VENTILATOR SETTINGS FOR THE HAMILTON G5 WERE CURRENTLY AT DURING THE TIME OF THE ABG DRAW. PT: 4582. DEVICE: 2881. REFERENCE REPORT: MW5177730.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242759 HAMILTON G5 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK HAMILTON MEDICAL AG G5

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Hospitalization| O