BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4222291 · Received November 3, 2014

    Report

    Report Number
    2031642-2014-01339
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 9, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION / ROOT CAUSE: THIS CUSTOMER RETURNED POWER SUPPLY WAS TESTED AND NO FAILURES WERE 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 FAILED TO START AFTER BEING SHUT DOWN FOR TESTING. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT OR HARM. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. DURING EVALUATION, THE FSE REPORTED THE VENTILATOR RESTARTED AND REVIEW OF THE DEVICE DIAGNOSTIC LOG NOTED A POWER FAIL OCCURRENCE. THE SERVICE ENGINEER REPLACED THE POWER SUPPLY TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702411 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1