BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIELITE DELUXE W/ SIDESTREAM

    MDR report key: 2481611 · Received February 22, 2012

    Report

    Report Number
    2243193-2012-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 23, 2012
    Report Date
    February 2, 2012
    Manufacturer
    RESPIRONICS NEW JERSEY INC.
    Product Code
    CAF
    PMA / PMN Number
    K060404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTED PT USING UNIT WITH BATTERY IN PLACE AND PLUGGED INTO THE WALL. THE CORD STARTED BURNING AND SMOKING. PT STOPPED USE AND WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIELITE DELUXE W/ SIDESTREAM MINIELITE CAF RESPIRONICS NEW JERSEY INC. RDD483 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR