BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3790467 · Received May 5, 2014

    Report

    Report Number
    1031452-2014-01164
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 2, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, THE MACHINE WAS RUNNING THEN THERE WAS AN ODD SOUND. SO THEY UNPLUGGED IT. AT THE SAME TIME THEY UNPLUGGED IT THERE WAS A PUFF OF WHITE DUST. THE UNIT FELT HOT TO TOUCH. THEY UNIT WAS REMOVED FROM THE ROOM. ONCE OPENED, THEY SAID THERE WAS A BROWN HAZE IN ALL OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269140 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other