BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4182779 · Received October 17, 2014

    Report

    Report Number
    2031642-2014-01248
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE: (B)(6) 2014. THE POWER SUPPLY WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WOULD NOT POWER ON AC. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. 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
    661543 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1