BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2083266 · Received May 10, 2011

    Report

    Report Number
    2031642-2011-00157
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD NOT OPERATE ON AC POWER, ONLY ON BACKUP BATTERY POWER. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. UNIT IS OUT OF WARRANTY, THEREFORE SERVICE TECHNICIAN RECOMMENDED CUSTOMER REPLACE THE POWER SUPPLY TO CORRECT THE REPORTED PROBLEM. CUSTOMER REMOVED POWER SUPPLY FROM DEVICE AND RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS OF THE POWER SUPPLY REVEALED A MALFUNCTION THAT MAY RESULT IN THE UNIT SHUTTING DOWN DURING OPERATION WITH AN ACTIVE BACKUP ALARM WHEN AC POWER IS RESTORED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1