BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3331180 · Received September 6, 2013

    Report

    Report Number
    1031452-2013-01853
    Event Type
    Malfunction
    Date Received
    September 6, 2013
    Report Date
    August 28, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 1031452-2013-01853.

    Description of Event or Problem · 1

    PROVIDER STATES UNIT COMES ON AND RUNS FOR 30 TO 40 MINUTES AND THEN GOES DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444744 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other