BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3870079 · Received June 12, 2014

    Report

    Report Number
    2031642-2014-00480
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 16, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION / ROOT CAUSE: THE SECOND GENERATION POWER SUPPLY WAS TESTED WITH NO FAILURES IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED ON STARTUP DUE TO A VENT INOP. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER CONFIRMED THE REPORTED PROBLEM. THE MANUFACTURERS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND REPLACED THE POWER SUPPLY TO CORRECT THE REPORTED PROBLEM. THE DEVICE PASSED ALL MANUFACTURER REQUIRED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348625 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1