BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3973444 · Received August 1, 2014

    Report

    Report Number
    2031642-2014-00774
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE BACKUP BATTERY IS NOT CHARGING. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE CUSTOMER REPORTED THE VENTILATOR WOULD OPERATE ON AC POWER BUT THE BACKUP BATTERY WOULD NOT HOLD A CHARGE. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR FAILED THE BACKUP BATTERY TEST. THE CUSTOMER DECLINED REPLACEMENT OF THE BATTERY DUE TO COST. POWER FAILURE DUE TO LOSS OF AC OR BATTERY POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION. PROPER CARE, MAINTENANCE AND TESTING SHOULD BE PERFORMED WHEN USING BATTERY POWER SOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450628 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1