BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 4102594 · Received September 19, 2014

    Report

    Report Number
    2031642-2014-01072
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 24, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CPU PCBA REPLACED AS A PRECAUTION.

    Additional Manufacturer Narrative · 1

    CONCLUSION / ROOT CAUSE: THE REPORTED COMPLAINT OF UNKNOWN RESTART (E/C 4) WAS NOT DUPLICATED. NO FAULT WAS FOUND ON THE RETURNED CPU PCBA & SENSOR PCB. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE DEVICE PERFORMED AN UNKNOWN RESTART DURING NORMAL VENTILATION OPERATION. THE DEVICE WAS BEING TESTED, IT WAS NOT ON A PATIENT. THE FSE WAS UNABLE TO DUPLICATE THE PROBLEM, BUT REPLACED THE CPU PCBA AS A PRECAUTION. THE DEVICE PASSED ALL MANUFACTURERS REQUIRED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581537 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1