BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3083550 · Received April 29, 2013

    Report

    Report Number
    1031452-2013-00811
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    UNIT SHUTS DOWN AND THE RESET BUTTON POPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185918 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5LX02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other