BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17772279 · Received September 19, 2023

    Report

    Report Number
    3001421318-2023-12567
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    July 7, 2022
    Report Date
    September 18, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG MORE THAN ONE YEAR AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. 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. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH 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 FOR TREATMENT. NO ROOT CAUSE COULD BE DETERMINED AS THE PROBLEM WAS NOT REPRODUCIBLE. THE CORRECTION MADE WAS UPGRADE AND TEST OF THE DEVICE. THERE WAS NO PATIENT OR USER HARM REPORTED.

    Description of Event or Problem · 0

    DEAR MILAD, A CUSTOMER HAD A PROBLEM WITH A G5 UNIT: THE UNIT SOFTWARE DIDN'T BOOT. WE COULD'NT REPRODUCE THE PROBLEM. SHNIDER SC2201353 PLEASE ADVISE B.R. ILAN OFMAN BEPEX LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890645 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown