BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 18910842 · Received March 15, 2024

    Report

    Report Number
    3001421318-2023-41195
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    January 12, 2023
    Report Date
    March 14, 2024
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    00730002856789
    PMA / PMN Number
    K201306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: 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 BEING PREPARED FOR USE. THE ROOT CAUSE OF THE ISSUE WAS NOT DETERMINED. THERE WAS NO PATIENT OR USER HARM.

    Description of Event or Problem · 0

    I WAS CALLED ABOUT A C3 NOT PASSING FLOW SENSOR CALIBRATION DURING PRE TESTS. WHEN I ARRIVED I PUT MY ADULT TEST CIRCUIT ON VENT AND RAN BOTH FLOW SENSOR CALIBRATION AND TIGHTNESS TESTS, BOTH PASSED. I THEN WENT TO TEST SW AS SEEN IN LOGS AND RAN MULTIPLE CALIBRATIONS ETC WITH ALL PASSING AS WELL NO PROBLEM. THE CUSTOMER THEN PROVIDED A NEW F&P NEO CIRCUIT, A BRAND NEW FLOW SENSOR, AND AS SEEN IN LOGS PASSED FLOW SENSOR AND TIGHTNESS CALIBRATIONS. AFTER SHOWING THE CUSTOMER A COUPLE CALIBRATIONS ETC THE NEO FLOW SENSOR CAL THEN STARTING FAILING EVERY SINGLE TIME, AT THE CIRCUIT, AT THE INSP OUTLET ETC. THIS VENT DID NOT HAVE THE NEO DAMPER 160595 ON FRONT BUT THE FACILITY DOES USE THEM FOR REFERENCE. PLEASE ADVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486419 HAMILTON MEDICAL AG HAMILTON-C3 CBK HAMILTON MEDICAL AG HAMILTON-C3 00730002856789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown