BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4241361 · Received November 10, 2014

    Report

    Report Number
    1525712-2014-07770
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    UNKNOWN
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE (B)(4) CONCENTRATOR HAS FAILED. POTENTIAL FOR NO O2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723937 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW UNKNOWN IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other