BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17697271 · Received September 7, 2023

    Report

    Report Number
    3001421318-2023-24042
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    February 24, 2021
    Report Date
    September 6, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION "FLOW SENSOR CALIBRATION FAILS" CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED. ANOTHER VENTILATOR MUST BE MADE AVAILABLE. THE ROOT CAUSE CANNOT BE DETERMINED. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE.

    Description of Event or Problem · 0

    "TIGHTNESS TEST" AND "FLOW SENSOR CALIBRATION" ARE NG. WHEN I CHECKED ON (B)(6) ONLY "FLOW SENSOR CALIBRATION" WAS NG. WHEN I CHECKED AGAIN TODAY, BOTH WERE NG. I HAVE CHECKED WITH MULTIPLE CIRCUITS AND THERE IS A REPRODUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121753 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown