BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMILTON MEDICAL AG

    MDR report key: 16705015 · Received April 8, 2023

    Report

    Report Number
    3001421318-2023-01181
    Event Type
    Malfunction
    Date Received
    April 8, 2023
    Date of Event
    May 12, 2022
    Report Date
    July 12, 2023
    Manufacturer
    HAMILTON MEDICAL AG
    Product Code
    CBK
    UDI-DI
    07630002800747
    PMA / PMN Number
    K181216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 MALFUNCTION 'FLOW SENSOR CALIBRATION FAILS' CAN LEAD TO A DELAY IN THE THERAPY SINCE THE VENTILATOR CANNOT BE USED. ANOTHER VENTILATOR MUST BE MADE AVAILABLE. THE ROOT CAUSE IS A MALFUNCTION OF THE PRESSURE SENSOR ASSEMBLY. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT. 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 SIMILAR TO 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: "DEVICE WILL NOT CALIBRATE THE FLOW SENSOR AFTER A FULL CALIBRATION CHECK. FOLLOWING CHECKS THAT HAVE FAILED: FLOW SENSOR CALIBRATION FAILED, AUTO ZERO PAW FAILED, NEB VALVE OFF FAILED, FLOW SYSTEM TEST PROXIMAL FLOW SENSOR QAW FAILED." FLOW SENSOR COULD NOT BE CALIBRATED WHICH MAY LEAD TO DELAYED RESCUE TIME, RESULTING IN THE PATIENT'S BLOOD OXYGEN SATURATION DROPPING, SUFFOCATION AND LIFE THREATENING. THE ISSUE OCCURRED DURING PRE-OPERATIONAL CHECK. NO PATIENT INVOLVED. NO HARM TO PATIENT OR USER. 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 USE IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    DEVICE WILL NOT CALIBRATE THE FLOW SENSOR AFTER A FULL CALIBRATION CHECK. FOLLOWING CHECKS THAT HAVE FAILED: FLOW SENSOR CALIBRATION FAILED. AUTO ZERO PAW FAILED. NEB VALVE OFF FAILED. FLOW SYSTEM TEST PROXIMAL FLOW SENSOR QAW FAILED.

    Description of Event or Problem · 0

    DEVICE WILL NOT CALIBRATE THE FLOW SENSOR AFTER A FULL CALIBRATION CHECK. FOLLOWING CHECKS THAT HAVE FAILED: FLOW SENSOR CALIBRATION FAILED, AUTO ZERO PAW FAILED, NEB VALVE OFF FAILED, , FLOW SYSTEM TEST PROXIMAL FLOW SENSOR QAW FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414956 HAMILTON MEDICAL AG HAMILTON-C1 CBK HAMILTON MEDICAL AG HAMILTON-C1 07630002800747

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown