BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2051020 · Received April 12, 2011

    Report

    Report Number
    2031642-2011-00122
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    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

    WHILE ONSITE TO PERFORM PREVENTIVE MAINTENANCE ON THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE VENTILATOR WOULD NOT OPERATE ON AC POWER. THE CUSTOMER DID NOT REPORT THE OCCURRENCE DURING ANY PREVIOUS USAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO ADDRESS THE FINDING. EXTENDED SELF TESTING AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND 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