BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17609883 · Received August 24, 2023

    Report

    Report Number
    3001421318-2023-28355
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    May 20, 2020
    Report Date
    August 22, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    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 NOT IN USE. THE ROOT CAUSE WAS DETERMINED AS PER THE RGA#75414 TO BE A FAILURE TRACED TO A FAULTY PRESSURE SENSOR BOARD. IN CONSEQUENCE THE PRESSURE SENSOR ASSEMBLY WAS REPLACED, AND NO OTHER FAILURES WERE REGISTERED FOR THIS MACHINE. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    THE MACHINE IS UNABLE TO PASS TIGHTNESS AND FLOW SENSOR TESTS.FLOW TEST-SERVICE MODE, PROXIMAL FLOW SENSOR QAW - NOT OK; AUTOZERO TEST, QAW; PAW, PVENT MONITOR AND PVENT CONTROL - NOT OK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306733 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown