BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3902469 · Received June 30, 2014

    Report

    Report Number
    2031642-2014-00574
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS DISPLAYING A 'NO BACKUP BATTERY' MESSAGE WHEN THERE WAS A BATTERY IN USE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) VERIFIED THE REPORTED PROBLEM, AND REPORTED VOLTAGES FROM THE BATTERY AND THE VENTILATOR WERE LOW. THE FSE OBSERVED HEAT RELATED DAMAGE TO A POWER SUPPLY PCB BOARD. THE FSE REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS.

    Description of Event or Problem · 1

    FACTORY ANALYSIS OF THE RETURNED POWER SUPPLY REVEALED TRANSISTOR AND INTEGRATED CIRCUIT FAILURES RESULTED IN THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380251 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1