BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT

    MDR report key: 617780 · Received August 10, 2004

    Report

    Report Number
    2031642-2004-00145
    Event Type
    Other
    Date Received
    August 10, 2004
    Date of Event
    July 13, 2004
    Report Date
    July 13, 2004
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING SAFETY VALVE OPEN,(SVO). THE VENTILATOR WAS IN USE ON A PATIENT , AND THERE WAS NO PATIENT HARM.

    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 NA