BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3841605 · Received May 30, 2014

    Report

    Report Number
    2031642-2014-00421
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 5, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE EVALUATION AND REPAIR PENDING.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE IS ATTEMPTING TO REBOOT. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE ON A PATIENT THEREFORE NO PATIENT HARM. REVIEW OF THE DEVICE DIAGNOSTIC CODE LOG INDICATED A +-24/12 VOLT POWER FAILURE OCCURRENCE DURING OPERATION. INITIAL SERVICE EVALUATION AND REPAIR ARE IN PROGRESS.

    Description of Event or Problem · 1

    THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE VENTILATOR WOULD NOT TURN ON IN DIAGNOSTIC MODE. THE FSE REPORTED THE UNIT TRIES TO START AND THEN THE SCREEN GOES BLANK. THE FSE REPORTED WHEN THE VENTILATOR BOTTOM ENCLOSURE WAS DISCONNECTED FROM THE UPPER ENCLOSURE THE UNIT STARTED UP IN DIAGNOSTIC MODE. THE FSE RECONNECTED THE BOTTOM ENCLOSURE AND REPORTED THE UNIT STARTS UP NORMALLY IN BOTH NORMAL VENTILATION AND DIAGNOSTIC MODES. THE FSE REPORTED THE VENTILATOR PASSED EXTENDED SELF TESTING. THE FSE REPORTED THE CUSTOMER STATED THEY WILL FOLLOW WITH A RUN-IN OF THE DEVICE AND RUN OVERNIGHT TO COMPLETE CHECKOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317998 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1