BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3896761 · Received June 26, 2014

    Report

    Report Number
    1031452-2014-02536
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Report Date
    May 27, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATED THAT THE XPO100B PORTABLE CONCENTRATOR WILL TURN ON BUT THE COMPRESSOR WILL NOT KICK IN FOR THE UNIT TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373907 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other