BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16730235 · Received April 13, 2023

    Report

    Report Number
    3001421318-2023-01336
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    February 3, 2020
    Report Date
    August 14, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002808590
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 NO, 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: THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE TE 233003 AND TE 233004 MALFUNCTION CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED (IFU: "MUST BE SERVICED"). A FULLY FUNCTIONING VENTILATOR NEEDS TO BE PREPARED. THE ROOT CAUSE OF THE VENTILATOR TO ALARM WITH TE 233003 AND TE 233004 WAS DETERMINED TO BE THE CONTAMINATION WITH FLUIDS OF THE PATIENT BREATHING CIRCUIT AND CONNECTED FLOW SENSOR. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT, WHILE THE MEDICAL DEVICE WAS USED FOR TREATMENT. THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS NO, 2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. DETAILED COMPLAINT AND FAILURE DESCRIPTION: "TF233003 UND TT 2330034." TECHNICAL EVENT: 233003 - AUTOZERO PAW FAIL AND TF 233034 - AUTOZEROPVENTMONITOROUTOFRANGE. VENTILATION CONTINUES. AUTOZEROVALVE DEFECTIVE. PROXIMAL FLOW MEASUREMENT INCORRECT. LOW MINUTE VOLUME. NOT ENOUGH MINUTE VOLUME DELIVERED. NO PATIENT INVOLVED. NO HARM TO PATIENT OR USER. THE EVENT MAY LEAD TO HYPOVENTILATION (ALSO KNOWN AS RESPIRATORY DEPRESSION) WHICH OCCURS WHEN VENTILATION IS INADEQUATE TO PERFORM NEEDED RESPIRATORY GAS EXCHANGE. BY DEFINITION IT CAUSES AN INCREASED CONCENTRATION OF CARBON DIOXIDE (HYPERCAPNIA) AND RESPIRATORY ACIDOSIS. HYPOVENTILATION CAN BE CONSIDERED A PRECURSOR TO HYPOXIA AND ITS LETHALITY IS ATTRIBUTED TO HYPOXIA WITH CARBON DIOXIDE TOXICITY. THE ISSUE IS NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT IS LIKELY TO CAUSE SERIOUS INJURY OR DEATH TO PATIENT OR USER. FURTHERMORE IS THE ISSUE NOT LIKELY TO BE SERIOUS TO PUBLIC HEALTH BUT IS LIKELY TO CAUSE SERIOUS INJURY OR DEATH TO PATIENT OR USER IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    TECHNICAL EVENT: 232003, 233003, 233004.

    Description of Event or Problem · 0

    TECHNICAL EVENT: 232003, 233003, 233004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249568 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 07630002808590

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown