BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3163558 · Received June 11, 2013

    Report

    Report Number
    1031452-2013-01101
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES CONCENTRATOR RUNS FOR 3 HOURS THEN SHUTS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264822 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS TPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other