BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17497605 · Received August 10, 2023

    Report

    Report Number
    3001421318-2023-02863
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    July 1, 2023
    Report Date
    August 10, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    505

    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: THE VENTILATOR IS USED AS A DEMO UNIT. WHEN OUR ENGINEER SWITCHED ON THE VENTILATOR THE VENTILATOR STARTED TO SHOWING THE FOLLOWING TECHNICAL EVENTS TE 285001, 285002, 231022, 233001, 233003, 233004, 233006, 246010 AND FAN FAILURE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851931 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown