BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3997920 · Received August 11, 2014

    Report

    Report Number
    3008262382-2014-00512
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    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

    PER REPAIR STATEMENT, ALARMING OR RED LIGHT, OUTLET SPOUT BROKEN, AND COMPRESSOR LOUD.

    Description of Event or Problem · 1

    PER PROVIDER, MANIFOLD IS NOT SHIFTING. PER REPAIR STATEMENT, ALARMING OR RED LIGHT, OUTLET SPOUT BROKEN, AND COMPRESSOR LOUD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475901 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other