BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18202828 · Received November 23, 2023

    Report

    Report Number
    3001421318-2023-19229
    Event Type
    Malfunction
    Date Received
    November 23, 2023
    Date of Event
    October 30, 2021
    Report Date
    November 22, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG TWO 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 USE. THE ROOT CAUSE COULD NOT BE DETERMINED AND THE DEVICE PASSED ALL TESTS IN TSW. THERE WAS NO PATIENT OR USER HARM REPORTED. THE C-CODE "4256 - MALFUNCTION OBSERVED WITHOUT CONCLUSIVE FINDING" IS NOT AVAILABLE IN ESUBMITTER. THIS IS WHY IT WILL BE MARKED HERE IN THE CONCLUSION.

    Description of Event or Problem · 0

    I HAD AN ISSUE WITH THE HAMILTON C6 VENTILATOR TODAY. THE ISSUE WAS WITH AN TBI PATIENT WHO HAD JUST CHUFFED. FOLLOWING SUCTIONING THE VENTILATOR WAS UNABLE TO REACH THE SET PRESSURE. AS SEEN IN THE PICTURE BELOW. THINKING IT WAS AN ISSUE OF A LARGE INSPIRATORY DRIVE, I INCREASED THE PRESSURE SUPPORT GRADUALLY UNTIL 30 CMH2O WITHOUT EFFECT. THE PMAX WAS NOT INCREASED AND THE PRESSURE WAVE STILL HAD THE APPEARANCE OF FLOW STARVATION. I THEN NOTICED THAT PEAK FLOWS WERE ABOUT 37-40 L/MIN, WHICH IN NO WAY SHOULD CAUSE FLOW STARVATION. TO TRY AND AMEND THE ISSUE I CHANGED TO A CONSTANT FLOW CMV MODE TO GET A SET FLOW. UPON CHANGING BACK TO PRESSURE SUPPORT THE ISSUE RESOLVED ITSELF (LAST PICTURE). NOTICE THE PEAK FLOW OF 50 L/MIN WITH A PRESSURE SUPPORT OF ONLY 10 CMH2O IN THE LAST PICTURE. THE FLOW SENSOR WAS NOT VISIBLE CONTAMINATED OR FULL OF WATER. THERE WAS NO APPARENT LEAK IN THE CIRCUIT AND THE VENTILATOR GAVE THE LEAK AS 0%. TO ME THIS LOOK LIKE IT MUST BE AN ISSUE WITH THE VENTILATOR ANT NOT THE PATIENT. ANY IDEA WHAT COULD HAVE CAUSED THIS? COULD IT BE A PARTLY STUCK INSPIRATORY CHECK VALVE OR FAULTY INSPIRATORY HEPA-FILTER? OR AM I GETTING THIS WRONG?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223687 HAMILTON MEDICAL AG HAMILTON-C6 CBK HAMILTON MEDICAL AG HAMILTON-C6 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown