BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17070250 · Received June 6, 2023

    Report

    Report Number
    3001421318-2023-02186
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 23, 2022
    Report Date
    June 6, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 UNIT IS WORKING WITH A FAILURE IN THE FLOW SENSOR CALIBRATION, FLOW SENSOR CALIBRATION NOT OK. WE PERFORMED THE TEST SOFTWARE, EXPIRATORY VALVE TEST PASSES NOT OK. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674749 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown