BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17690348 · Received September 6, 2023

    Report

    Report Number
    3001421318-2023-22497
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    May 12, 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 OXYGEN SUPPLY FAILED, CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED. A NEW VENTILATOR NEEDS TO BE PREPARED. THE ROOT CAUSE OF THE VENTILATOR WAS A MALFUNCTION OF THE O2 MIXER VALVE NOT OPENING. (MECHANICALLY JAMMED DUE STORAGE OF THE DEVICE FOR A LONG PERIOD BEFORE USAGE). WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS PREPARED TO BE USED FOR TREATMENT OR DIAGNOSIS (PREOP CHECK). 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. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    WE RECEIVED A REQUEST THAT THE "OXYGEN SUPPLY FAILED" SOMETIMES OCCURS. I TOOK IT IN TO NK AND CHECKED IT OUT, BUT THERE IS NO REPRODUCTION FOR NORMAL USE. HOWEVER, I DID A REGULATION TEST ON THE MIXER I HAD PUSHED THE OTHER DAY. PIPING PRESSURE: ABOUT 3.0 BAR FLOW : 100L/MIN OXYGEN : 94 AND THE QO2 IS BELOW 90L/MIN AT TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918900 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown