BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 17815600 · Received September 26, 2023

    Report

    Report Number
    3001421318-2023-13358
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    May 27, 2022
    Report Date
    September 25, 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 ALMOST 1 YEAR 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 USED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE EXPIRATORY VALVE. IN CONSEQUENCE (CORRECTION) THE EXPIRATORY VALVE WAS REPLACED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    ISSUE WAS DISCONNECTION ON VENT SIDE, I MADE A MISTAKE OF THINKING IT WAS A PANEL DISCONNECTION. I REPLACED THE ESM BOARD. DURING SERVICE SOFTWARE IT THE UNIT WOULD NOT PASS THE EXP VALVE AND TIGHTNESS TEST. AFTER REPLACING THE EXP VALVE ASSEMBLY THE UNIT PASS TIGHTNESS TEST AND EXP VALVE BUT THE APRV WAVE FORM IS NOT CORRECT WAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831007 HAMILTON MEDICAL AG HAMILTON-G5 CBK HAMILTON MEDICAL AG HAMILTON-G5 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown