BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3951263 · Received July 22, 2014

    Report

    Report Number
    2031642-2014-00713
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 30, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFR DATE: 09/3/2014. THE REPORTED COMPLAINT OF EXHALATION PRESSURE OUT OF RANGE ERROR CODE 3108 WAS NOT DUPLICATED. NO FAULT WAS FOUND ON THE RETURNED SENSOR PCB. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE UNIT FAILED PRE-USE TESTING DUE TO AN EXHALATION PRESSURE OUT OF RANGE. DURING NORMAL OPERATION, AN OUT OF SPECIFICATION EXHALATION PRESSURE COULD BE DETRIMENTAL TO A PATIENT IF IN USE. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED DURING TESTING THE EXHALATION PRESSURE WOULD INTERMITTENTLY NOT ZERO WHEN PRESSURE IS ZERO. THE FSE REPLACED THE SENSOR PCB BOARD TO ADDRESS THE REPORTED PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428193 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1