BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16859619 · Received May 3, 2023

    Report

    Report Number
    3001421318-2023-01618
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 3, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800372
    PMA / PMN Number
    K121225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HAMILTON MEDICAL AG`S CONCLUSION: INVESTIGATION ONGOING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: DETAILED COMPLAINT AND FAILURE DESCRIPTION: TF 231013 QO2 FLOW SENSOR DEFECT. SELFTEST AT START UP NOT PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196189 HAMILTON MEDICAL AG HAMILTON-C2 VENTILATOR CBK HAMILTON MEDICAL AG 160001 07630002800372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown