BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2923464 · Received January 22, 2013

    Report

    Report Number
    1031452-2013-00116
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 18, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(6) -THE DEALER REPORTED THAT THE XPO100B PORTABLE CONCENTRATOR WAS MALFUNCTIONING. THERE WAS NO AVAILABLE INFORMATION IN REGARDS TO THE NATURE OF THE MALFUNCTION, AND / OR IF THE UNIT ALARMED AS DESIGNED, INDICATING TO THE PATIENT TO SEEK ALTERNATIVE OXYGEN OPTION. NO PATIENT INJURY WAS REPORTED,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29474 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other