BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1951090 · Received January 6, 2011

    Report

    Report Number
    2031642-2011-00007
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    POWER SUPPLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WOULD NOT OPERATE ON AC POWER, ONLY ON BACKUP BATTERY POWER. THE CUSTOMER REPORTED THE UNIT WAS NOT IN USE ON A PATIENT, THEREFORE, THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE CUSTOMER REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. FACTORY ANALYSIS OF THE POWER SUPPLY REVEALED A MALFUNCTION THAT COULD RESULT IN A LOSS OF AC POWER DURING OPERATION. MALFUNCTION OF THE POWER SUPPLY AS NOTED DURING USE COULD CAUSE THE VENTILATOR TO SHUT DOWN AND ALARM. IF A FAILURE OF THE POWER SUPPLY OCCURS DURING USE AND THE VENTILATOR SHUTS DOWN DUE TO A LOSS OF AC POWER, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE.

    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