BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2782941 · Received February 26, 2007

    Report

    Report Number
    2031642-2008-00053
    Event Type
    Other
    Date Received
    February 26, 2007
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2009
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A RESPIRATORY THERAPIST (RT) WAS PREPARING THE VENTILATOR FOR PATIENT USE. RT PLUGGED VENTILATOR INTO AC POWER AND POWERED THE VENTILATOR ON. RT ATTACHED THE VENTILATOR TO OXYGEN SOURCE, AND REPORTED HEARING A HISSING SOUND AT THE REAR OF THE VENTILATOR. RT REMOVED SCREWS FROM THE FAN FILTER ASSEMBLY, CAUSING STANDOFFS TO FALL INTO THE INTERIOR OF VENTILATOR. THE RT REPORTED A FIRE STARTED AT THAT MOMENT INSIDE THE VENTILATOR. THE FIRE WAS EXTINGUISHED IMMEDIATELY, AND THERE WAS NO PATIENT OR STAFF HARM. USER ERROR CONTRIBUTED TO THIS EVENT. PER THE ESPRIT OPERATOR¿S MANUEL, CAUTION: DO NOT REMOVE ANY SCREWS FROM THE COOLING FAN AREA. REMOVING SCREWS FROM THIS AREA WILL RESULT IN DAMAGE TO INTERNAL COMPONENTS. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS.

    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 NO Other