BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3965205 · Received July 29, 2014

    Report

    Report Number
    2031642-2014-00759
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 9, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED AND SHUTDOWN DURING NORMAL VENTILATION OPERATION IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THAT TRENDING HISTORY FROM THE DAY OF THE REPORTED PROBLEM WAS REVIEWED AND IT WAS NOTED THAT THE VENTILATOR ALARMED LOW BATTERY APPROX. 1:28AM. THE FSE REPORTED REVIEW OF THE DIAGNOSTIC HISTORY NOTED A 24V/ +-12V/POWER FAIL FAILURE OCCURRENCE FOLLOWED BY A RESTART WHICH MAY HAVE BEEN DUE TO THE BATTERY DEPLETING. THE FSE REPORTED INTERNAL AND EXTERNAL INSPECTION OF THE DEVICE FOUND NO ISSUES, AND BOTH EXTERNAL AND BACKUP BATTERIES WERE FULLY CHARGED. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND PASSED. THE FSE REPORTED NO PROBLEM WAS FOUND WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442079 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1