BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIELITE WITH SIDESTREAM PLUS DELUXE

    MDR report key: 2571594 · Received May 2, 2012

    Report

    Report Number
    2243193-2012-00003
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 2, 2012
    Report Date
    May 1, 2012
    Manufacturer
    RESPIRONICS NEW JERSEY, INC.
    Product Code
    CAF
    PMA / PMN Number
    K060404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THEY WERE USING THE UNIT AND IT STARTED SMOKING AND CAUGHT FIRE AND MELTED THE BATTERY AND UNIT. PRODUCT CONTAINS LITHIUM ION BATTERY. RESPIRONICS IS MONITORING DEFECTS CONNECTED TO THE BATTERY WITH EMPHASIS ON DIFFERENTIATING BETWEEN WHAT MIGHT BE RELATED TO DESIGN, MANUFACTURING, OR PATIENT MISUSE/ABUSE. AT THIS TIME, THERE HAVE BEEN NO COMPLAINTS ASSOCIATED WITH DESIGN OR MANUFACTURING DEFECTS, BUT RESPIRONICS WILL CONTINUE TO CLOSELY MONITOR BATTERY-RELATED COMPLAINTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA