BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT

    MDR report key: 604753 · Received May 23, 2005

    Report

    Report Number
    2031642-2005-00053
    Event Type
    Other
    Date Received
    May 23, 2005
    Date of Event
    April 11, 2005
    Report Date
    April 11, 2005
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR SHUT DOWN. THE VENTILATOR WAS IN USE ON A PT, AND THERE WAS NO PT HARM. IT IS UNK WHETHER AN ALARM SOUNDED AT THE TIME OF THE EVENT. THE RESPIRONICS SERVICE TECHNICIAN REPORTED WHEN PREPARING TO SERVICE THE VENTILATOR, A NOTE WAS FOUND ATTACHED TO THE VENTILATOR INDICATING THE VENTILATOR WENT VENT INOP. THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE A VENT INOP CONDITION, AND REPORTED THERE WERE NO DIAGNOSTIC CODES IN THE CODE LOG INDICATING THERE WAS A VENT INOP. THE SERVICE TECHNICIAN REPORTED THERE WERE DIAGNOSTIC CODES IN THE CODE LOG INDICATING AN OCCLUSION WAS DETECTED BY THE VENTILATOR WHICH OPENED THE SAFETY VALVE (SVO OCCLUSION). THE SERVICE TECHNICIAN PERFORMED BACKPRESSURE TESTING ON THE EXHALATION FILTER AND THE PRESSURE MEASURED 30CMH2O, INDICATING AN OCCLUDED FILTER. THE FILTER WAS DISCARDED. PERFORMANCE VERIFICATION TESTING WAS PERFORMED AND PASSED PER OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other