BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3822115 · Received May 20, 2014

    Report

    Report Number
    2031642-2014-00361
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 23, 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
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING SERVICE THE DEVICE FAILED THE BACK UP BATTERY TEST. IF A LOSS OF POWER OCCURS DURING USE IT COULD CAUSE THE UNIT TO SHUT DOWN DUE TO BACK-UP BATTERY NOT WORKING. THIS EVENT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. 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 CONFIRMED THE CUSTOMER REPORTED PROBLEM. THE SERVICE ENGINEER REPLACED THE BACK UP BATTERY TO ADDRESS THE FINDING AND REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299869 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1