BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3945431 · Received July 21, 2014

    Report

    Report Number
    2031642-2014-00703
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Report Date
    June 25, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED DATE: 08/07/2014. CONCLUSION / ROOT CAUSE: THE REPORTED COMPLAINT OF THE GAS VOLUME ACCURACY BEING OUT OF TOLERANCE WAS NOT DUPLICATED. NO FAULT WAS FOUND ON THE RETURNED SENSOR PCB. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR FAILED TESTING DURING PREVENTIVE MAINTENANCE SERVICE. THE FSE OBSERVED AN INHALATION AUTOZERO SOLENOID TEST FAILURE IN THE DEVICE DIAGNOSTIC HISTORY. IF THE SOLENOID MALFUNCTIONS, PRESSURE TRANSDUCER AUTOZEROING CANNOT BE PERFORMED AND AFFECTS THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT. THE FSE REPLACED THE SENSOR PCB BOARD TO CORRECT THE TEST FAILURE. FINAL TESTING WAS COMPLETED TO OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425692 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1