BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1964402 · Received January 19, 2011

    Report

    Report Number
    2031642-2011-00026
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    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 VENTILATOR WAS NOT IN USE ON A PATIENT, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. 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