BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17668396 · Received September 1, 2023

    Report

    Report Number
    3001421318-2023-17000
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    February 1, 2022
    Report Date
    August 30, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 LIKE 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 DURING VENTILATION. THE ROOT CAUSE WAS DETERMINED TO BE AUTOZERO VALVES ON SENSOR BOARD NOT WORKING PROPERLY. IN CONSEQUENCE THE SENSOR BOARD 2 WAS REPLACED (B)(4). THE UNIT PASSED ALL TESTS AND WAS THEN OPERATIONAL. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

     THE DP FLOW SENSOR SIGNAL HAS BEEN OUTSIDE THE RANGE. THE DP FLOW SENSOR ZERO CANNOT AJUST IN RANGE (1757 MICRO BAR) REPLACED SENSOR BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190434 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown