BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-G5

    MDR report key: 17076635 · Received June 7, 2023

    Report

    Report Number
    3001421318-2023-02193
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    April 24, 2023
    Report Date
    August 25, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800013
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG RECEIVED FURTHER INFORMATION FROM THE PARTNER: IT WAS LEARNED THAT THE SITUATION REPORTED BY THE HOSPITAL WAS NOT TRUE. OUR AGENT ENGINEER CAME FOR INVESTIGATION, AND THE MACHINE WAS IN NORMAL USE, AND THERE WAS NO RECORD OF "LARGE ERROR OF TIDAL VOLUME" DESCRIBED IN THE REPORT. NO ONE IN THE DEPARTMENT REPORTED THE ADVERSE EVENT, AND NO ONE IN THE EQUIPMENT DEPARTMENT REPORTED THE ADVERSE EVENTS. THE CONTACT PHONE NUMBER IN THE REPORT WAS INVALID AND COULD NOT BE CONTACTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION FROM THE HOSPITAL REPORT:WHEN THE EQUIPMENT DEPARTMENT ARRANGED FOR METROLOGICAL TESTING OF THE INJECTION PUMP IN THE ENTIRE HOSPITAL, IT WAS FOUND THAT THERE WAS A LARGE ERROR BETWEEN THE SET VALUE AND THE DISPLAYED VALUE OF THE TIDAL VOLUME OF THE VENTILATOR IN THE EIC DEPARTMENT HOSPITAL ANALYSIS: INTERNAL COMPONENT FAILURE

    Description of Event or Problem · 0

    HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION FROM THE HOSPITAL REPORT: WHEN THE EQUIPMENT DEPARTMENT ARRANGED FOR METROLOGICAL TESTING OF THE INJECTION PUMP IN THE ENTIRE HOSPITAL, IT WAS FOUND THAT THERE WAS A LARGE ERROR BETWEEN THE SET VALUE AND THE DISPLAYED VALUE OF THE TIDAL VOLUME OF THE VENTILATOR IN THE EIC DEPARTMENT HOSPITAL ANALYSIS: INTERNAL COMPONENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606321 HAMILTON-G5 HAMILTON-G5 VENTILATOR CBK HAMILTON MEDICAL AG 159001 07630002800013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown