BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17608827 · Received August 23, 2023

    Report

    Report Number
    3001421318-2023-21610
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    July 1, 2021
    Report Date
    August 22, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K022679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 ALMOST 2 YEARS 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 IN A TEST PHASE. THE ROOT CAUSE WAS DETERMINED TO BE THE AGING OF THE DEVICE. IN CONSEQUENCE THE DEFECTIVE COMPONENT WAS REPLACED, AND NO FURTHER ISSUE OCCURRED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    THE UNIT SHOWS THE TF#8 ALARM CODE 28 IN NORMAL USING. WE ENTER THE TSW TEST7 AND FIND THE VAW IS NOT OK. WE HAVE CHECKED THE RIBBON CABLE AND J5 CONNECTOR ON THE MAINBOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301199 HAMILTON MEDICAL AG RAPHAEL CBK HAMILTON MEDICAL AG RAPHAEL 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown