BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2163117 · Received July 15, 2011

    Report

    Report Number
    2031642-2011-00227
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD NOT POWER ON. THE VENTILATOR WAS NOT IN USE, THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS. 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