BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2110717 · Received June 1, 2011

    Report

    Report Number
    2031642-2011-00180
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSOTMER REPORTED THE VENTILATOR SHUT DOWN AND ALARMED DURING USE ON A PATIENT AND HAD AN ODOR OF OVERHEATING. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN VERIFIED THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE MAIN PCB BOARD TO ADDRESS THE REPORTED PROBLEM. FINAL APPLICABLE TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS. FACTORY FAILURE ANALYSIS OF THE MAIN PCB BOARD REVEALED A SHORTED COMPONENT, WHICH MAY RESULT IN A LOSS OF AC POWER. IF A LOSS OF AC POWER OCCURS DURING USE AND THE VENTILATOR SHUTS DOWN, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1