BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUET LX N. AM. DELUXE

    MDR report key: 885761 · Received September 20, 2006

    Report

    Report Number
    2518422-2006-00057
    Event Type
    Malfunction
    Date Received
    September 20, 2006
    Date of Event
    August 1, 2006
    Report Date
    August 21, 2006
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED FROM A PT USING THE DEVICE THAT HE REMOVED HIS MASK, POWERED THE DEVICE OFF AND THEN LEFT THE ROOM. WHEN THE PT RETURNED TO THE ROOM WHERE THE DEVICE WAS LOCATED, HE REPORTED THAT THERE WAS A FLAME COMING FROM THE REAR OF THE DEVICE. THERE WAS NO REPORTED PT HARM. REQUESTS TO HAVE THE DEVICE RETURNED FOR EVALUATION HAVE NOT YET BEEN HONORED. A FOLLOW-UP REPORT WILL BE FILED WHEN ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET LX N. AM. DELUXE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BTT RESPIRONICS, INC. 622175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other