BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2371769 · Received June 23, 2010

    Report

    Report Number
    2031642-2010-00145
    Event Type
    Death
    Date Received
    June 23, 2010
    Date of Event
    May 21, 2010
    Report Date
    May 27, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RETURNED TO MFR.

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR REPORTED A PT DEATH AFTER A VENT INOP OCCURRENCE DUE TO A FLOW SENSOR FAULT. THE VENTILATOR HAS BEEN REQUESTED FOR RETURN TO THE MFR FOR FUTURE ANALYSIS. FURTHER EVENT INFO IS UNK AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death