BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3902677 · Received June 30, 2014

    Report

    Report Number
    2031642-2014-00576
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 25, 2014
    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

    FACTORY ANALYSIS OF A RETURNED POWER SUPPLY REVEALED A FUSE FAILURE WHICH MAY RESULT IN A VENT INOP AIR LIFTOFF FAILURE OR THE BLOWER SHUTTING OFF DURING OPERATION WITH ALARM IN NORMAL VENTILATION MODE. EVALUATION OF THE FUSE REVEALED IT OPENED AT THE END CAP. THE VENT INOP INDICATOR SIGNALS THE OPERATOR THAT THE VENTILATOR IS NOT CAPABLE OF SUPPORTING VENTILATION AND REQUIRES SERVICE. DURING A VENT INOP CONDITION, THE VENTILATOR ENTERS A SAFE STATE, WHERE THE SAFETY VALVE IS OPENED AND NEW ALARM CONDITION DETECTION IS DISCONTINUED. IF THE VENTILATOR IS ATTACHED TO A PATIENT WHEN THIS CONDITION IS DETECTED, THE VENTILATOR MUST BE REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380656 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1