BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3833717 · Received May 27, 2014

    Report

    Report Number
    2031642-2014-00394
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    April 29, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    DURING PERFORMANCE VERIFICATION TESTING OF THE DEVICE THE MANUFACTURERS SERVICE TECHNICIAN NOTED THE DEVICE FAILED THE BACKUP BATTERY TEST. THE SERVICE TECHNICIAN REPLACED THE BACKUP BATTERY TO CORRECT THE PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS AND PASSED. PER THE VENTILATOR OPERATORS MANUAL, THE BATTERY OPERATING LIFE MAY BE AFFECTED BY BATTERY AGE AND THE NUMBER OF TIMES IT HAS BEEN DISCHARGED AND RECHARGED. OVER TIME THE BATTERY WILL DEGENERATE AND WILL NOT PROVIDE THE SAME AMOUNT OF OPERATING TIME PER CHARGE THAT IS AVAILABLE FROM A FULLY CHARGED NEW BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310095 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1