BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4110051 · Received September 23, 2014

    Report

    Report Number
    1525712-2014-06199
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 3, 2014
    Manufacturer
    UNKNOWN
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER TBM (B)(6), THE (B)(6) HOME HAS MANY UNITS THAT ARE ALARMING WITH LESS THEN 100 HOURS, NO SERIAL NUMBERS PROVIDED OR EXACT NUMBER, HE WILL CALL BACK WITH MORE DETAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590145 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW UNKNOWN IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other