BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17651464 · Received August 30, 2023

    Report

    Report Number
    3001421318-2023-12032
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 2, 2022
    Report Date
    August 29, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 PREPARED FOR TREATMENT. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE PRESSURE SENSOR ASSEMBLY (PSA). IN CONSEQUENCE THE PRESSURE SENSOR ASSEMBLY HAS BEEN REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    USERS OBSERVED HUGE TIDAL VOLUME FLUCTUATIONS DURING SCMV VENTILATION. E.G. VT SET TO 400ML, OBSERVED VTE WAS AT 180ML, BUT WAVES WERE " AS EXPECTED ("NORMAL") AND DID NOT SHOW ANY ABNORMALITIES MATCHING THE FLUCTUATIONS". ATTACHED VIDEO SHOWS FLUCTUATIONS BETWEEN 230 AND 429ML (BREATH TO BREATH) WITH TIDAL SET TO 430ML WHILE WAVES LOOK IDENTICAL. HUMIDIFICATION AND NEBULIZATION ARE IN USE, FLOW SENSOR SHOWS CONDENSATION AND WATER MUST BE REMOVED FROM THE SYSTEM REGULARLY. H900 IS SET TO 34°C CHAMBER AND 36°C Y-PIECE. LEAK WAS SOMETIMES SHOWN TO BE 10-30%, BREATHING CIRCUIT DID NOT HAVE ANY LEAKS, SITUATION PERSISTED AFTER BC CHANGE. PATIENT HAS A THORACIC DRAIN, BUT NO LEAKAGE WAS OBSERVED. PATIENT IS PASSIVE (SEDATION AND RELAXATION). FURTHER INFORMATION WILL BE ADDED WHEN AVAILABLE. - PAT. WITH HISTORY OF HEAVY SMOKING, SEVERE COPD (GOLD IV D), PH OF 7 ON ARRIVAL, ACUTE RESPIRATORY FAILURE => INTUBATION AND SUBSEQUENT PNEUMOTHORAX (DRAIN INSERTED, STILL IN SITU). - PEEP 5MBAR + INTRINSIC PEEP 2-3MBAR - SCMV, VT CA. 430ML, RATE = 8 B/MIN, I:E = 1:5, PAUSE = 10%, RESISTANCE OF 30MBAR/(L/S)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316172 HAMILTON MEDICAL AG HAMILTON-C6 CBK HAMILTON MEDICAL AG HAMILTON-C6 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown