BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON-C1

    MDR report key: 20414719 · Received October 10, 2024

    Report

    Report Number
    3001421318-2024-02445
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 10, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG CASE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: ON (B)(6) WHEN PATIENT GAO WEIPING WAS USING A VENTILATOR FOR ASSISTED VENTILATION, THE VENTILATOR ALARM FLOW SENSOR MALFUNCTIONED AND THE EQUIPMENT DEPARTMENT WAS CONTACTED FOR REPAIR AND REPLACEMENT OF THE FLOW SENSOR. NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946151 HAMILTON-C1 HAMILTON-C1 CBK HAMILTON MEDICAL AG 161001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown