BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3965233 · Received July 29, 2014

    Report

    Report Number
    2031642-2014-00758
    Event Type
    Death
    Date Received
    July 29, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REFUSED MANUFACTURERS EVALUATION AT THIS TIME. CUSTOMER REFUSED MFR EVALUATION.

    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 THE PATIENT WAS BAGGED AND THE VENTILATOR CHANGED AND THE PATIENT LATER EXPIRED. THE DIRECTOR OF RESPIRATORY CARE REPORTED THAT ON (B)(6) 2014 AT APPROXIMATELY 3:00 PM THE STAFF ENTERED THE ROOM AND FOUND THE FEMALE PATIENT CYANOTIC AND THE VENTILATOR DISPLAYED A VENT INOP MESSAGE. THE PATIENT WAS BAGGED. THE RC DIRECTOR REPORTED THEY BELIEVE THE DEVICE WAS PLUGGED INTO AC BECAUSE THE DEVICE WAS SENDING AN ALARM TO THE BERNOULLI SYSTEM WHICH IS THE REMOTE ALARM SYSTEM THE FACILITY USES. THE CUSTOMER REPORTED THEY HAD BEEN UTILIZING ALBUTEROL AND ATROVENT NEBULIZED TREATMENTS. THE FACILITY ADMINISTRATOR CONTACTED MANUFACTURER'S PRODUCT SUPPORT (PSE) TO REPORT THE EVENT. THE FACILITY ADMINISTRATOR REPORTED ON (B)(6) DIAGNOSTIC CODES INDICATING 24V, +-12V OR POWER FAIL FAILURE AND RESTART OCCURRENCES WERE OBSERVED. THE FACILITY ADMINISTRATOR REPORTED THE VENTILATOR WAS TESTED INTERNALLY AND ALL TESTING PASSED WITH NO PROBLEM FOUND. THE FACILITY ADMINISTRATOR INQUIRED ABOUT THE DIAGNOSTIC CODES AND DISCUSSED A PREVIOUS SERVICE CALL FOR A REPORTED RESTART OCCURRENCE. PSE PROVIDED INFORMATION REGARDING THE DIAGNOSTIC CODES AND SERVICE VERIFICATION OF THE VENTILATOR. THE CUSTOMER IS NOT ALLOWING EVALUATION OF THE DEVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442258 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death BERNOULLI REMOTE ALARM SYSTEM| ALBUTEROL AND ATROVENT TREATMENTS