BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3941019 · Received June 19, 2014

    Report

    Report Number
    2031642-2014-00522
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 22, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT DISPLAYS BACK UP BATTERY NOT CONNECTED. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PT THEREFORE, THERE WAS NO PT INVOLVEMENT OR HARM. THE MFR'S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM, EVALUATED THE DEVICE AND THEY FOUND THE BACK UP BATTERY FAILED TESTING. THE FSE REPLACED THE BACKUP BATTERY TO ADDRESS THE REPORTED PROBLEM. FINAL APPLICABLE TESTING WAS PERFORMED PER OPERATING SPECS, SPECS AND PASSED PROPER CARE, MAINTENANCE AND TESTING SHOULD BE PERFORMED WHEN USING BATTERY POWER SOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360296 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1