BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2962700 · Received February 14, 2013

    Report

    Report Number
    1031452-2013-00307
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER STATING UNIT IS SHUTTING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65418 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XOP100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other