BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4140724 · Received October 3, 2014

    Report

    Report Number
    1525712-2014-06660
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 17, 2014
    Manufacturer
    UNKNOWN
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HORN ALARM HARNESS ON AN UNKNOWN CONCENTRATOR HAD A TORN WIRE, OUT OF THE BOX. MAY PREVENT UNIT FROM ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620882 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other