BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON C3

    MDR report key: 10733286 · Received October 23, 2020

    Report

    Report Number
    MW5097442
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 4, 2020
    Report Date
    October 22, 2020
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VENT STOPPED ON A PATIENT AND HAD RED AND GREEN BUTTONS ON SCREEN LIT. ASKED THEM TO SEND ME LOGS AND I'D TAKE A LOOK, LOOKS LIKE VENT LOST ALL POWER AND SHUT DOWN. ACCORDING TO THE SERVICE REPORT THIS DEVICE HAS NOT BEEN PM/SERVICE SOFTWARE TESTING SINCE LATE 2016. ADVISED CUSTOMER TO RECHECK ALL AREAS DEALING WITH POWER, ALSO ADVISED THEM FULL PM AND TESTING OF THIS DEVICE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195971 HAMILTON C3 VENTILATOR, CONTINUOUS, FACILITY USE CBK HAMILTON MEDICAL AG C3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention