BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4130036 · Received September 30, 2014

    Report

    Report Number
    2031642-2014-01120
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 4, 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

    SUPPLEMENTAL REPORT

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF THE RETURNED POWER SUPPLY REVEALED A CAPACITOR FAILURE THAT RESULTED IN THE REPORTED POWER ISSUE.

    Description of Event or Problem · 1

    DURING SERVICE FOR AN UNRELATED ISSUE THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR WOULD NOT POWER UP ON AC. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM. POWER FAILURE DUE TO LOSS OF AC OR BATTERY POWER MAY RESULT IN SHUTDOWN OF THE DEVICE DURING NORMAL VENTILATION OPERATION. THE FSE REPORTED THE POWER SUPPLY WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED TO OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609358 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1