BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3371561 · Received September 26, 2013

    Report

    Report Number
    1031452-2013-02009
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Report Date
    September 19, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR. REPORT # 1031452-2013-02009 INDICTING THE MODEL AS AN IRC5PO2V WITH A SERIAL NUMBER OF (B)(4). THE CORRECT MODEL IS TPO100B WITH A SERIAL NUMBER OF (B)(4).

    Description of Event or Problem · 1

    DEALER STATES UNIT SHUTS DOWN AFTER SEVERAL SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486935 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS TPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other