BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3971229 · Received July 31, 2014

    Report

    Report Number
    2031642-2014-00771
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 9, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DURING PREVENTIVE MAINTENANCE SERVICE OF THE DEVICE, THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR DID NOT OPERATE ON BACKUP BATTERY. THE FSE REPORTED DURING DIAGNOSTIC TESTING, THE AC POWER CORD WAS PULLED FROM THE WALL OUTLET AND THE UNIT SHUTDOWN. THE CUSTOMER DID NOT REPORT AN OCCURRENCE PRIOR TO SERVICE AND THERE WAS NO PATIENT HARM REPORTED. 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. THE FSE REPLACED THE BACKUP BATTERY TO ADDRESS THE FINDING. FINAL APPLICABLE TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446928 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1