BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17593670 · Received August 22, 2023

    Report

    Report Number
    3001421318-2023-10809
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    September 18, 2022
    Report Date
    August 21, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K121225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE TE 233003 AND TE 233004 MALFUNCTION CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED (IFU: "MUST BE SERVICED"). A FULLY FUNCTIONING VENTILATOR NEEDS TO BE PREPARED. THE ROOT CAUSE OF THE VENTILATOR TO ALARM WITH TE 233003 AND TE 233004 WAS DETERMINED TO BE A DEFECTIVE PRESSURE SENSOR ASSEMBLY (PSA) AND DEFECTIVE MAINBOARD. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT, WHILE THE MEDICAL DEVICE WAS USED FOR TREATMENT. 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 LIKE THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    DEAR MILAD, A CUSTOMER HAD A PROBLEM WITH THIS UNIT: ALERTED SEVERAL TIMES ON TF 233004. HE DID ALL THE TESTS BUT COULDN'T REPRODUCED THE PROBLEM. PLEASE ADVISE. B.R. ILAN OFMAN BEPEX LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329220 HAMILTON MEDICAL AG HAMILTON-C2 CBK HAMILTON MEDICAL AG HAMILTON-C2 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown