BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17623840 · Received August 25, 2023

    Report

    Report Number
    3001421318-2023-13012
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    June 24, 2022
    Report Date
    August 24, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K193228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 MORE THAN 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. 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 USED. THE ROOT CAUSE WAS DETERMINED TO BE CONTAMINATION ON THE EXPIRATORY VALVE PIN. IN CONSEQUENCE (CORRECTION) THE BIO-MED CLEANED THE PIN, TESTED THE VENTILATOR, AND RETURNED IT TO SERVICE. THERE WAS NO PATIENT OR USER HARM. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.

    Description of Event or Problem · 0

    DISCONNECTION ON VENT SIDE STAFF SAID THE MEDICINE MIGHT BE THE CAUSE OF THE ERROR . EXP VALVE WAS STICKY BUT RUNNING APRV THE WAVE FORM IS NOT. I ATTACHED A PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2083669 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown