BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1213364 · Received October 29, 2008

    Report

    Report Number
    2031642-2008-00218
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS IN USE ON A PATIENT WHEN THE POWER SURGED DURING A HURRICANE, AND THE UNIT WENT VENT INOP AND ALARMED. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED VENT INOP. THE SERVICE TECHNICIAN CONFIRMED WHEN THE VENTILATOR WAS POWERED ON IN DIAGNOSTICS, THE VENTILATOR WOULD OPERATE FOR A FEW MINUTES AND THEN RESTART, LOGGING A +24 VOLT FAILURE DIAGNOSTIC CODE. IN NORMAL VENTILATION MODE, THE UNIT WOULD QUICKLY SHUT DOWN AFTER POWER ON WITH A VENT INOP. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY TO CORRECT THE FINDINGS. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED TO OPERATING SPECIFICATIONS.

    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