BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3972863 · Received July 8, 2014

    Report

    Report Number
    2031642-2014-00631
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 12, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED DATE: 10/29/2014. CONCLUSION / ROOT CAUSE: THE POWER SUPPLY WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WOULD NOT POWER UP. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) FOUND THAT WHEN UNIT WAS PLUGGED INTO AC POWER THE BUS VOLTAGE IN HARDWARE SCREEN WAS READING BELOW SPECIFICATION. THE FSE REPLACED THE POWER SUPPLY TO CORRECT THE PROBLEM. APPLICABLE FINAL TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS. THE CUSTOMER REPORTED NO PT INVOLVEMENT, NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397871 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS, PRODUCT CODE: CBK CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1