BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4211419 · Received October 29, 2014

    Report

    Report Number
    1031452-2014-16604
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 8, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATED HE HAS HAD TO REPLACE THE ON OFF SWITCH ON SEVERAL UNITS. THE DEALER SAID THAT HE HAS HAD ABOUT 10 UNITS THUS FAR THAT HE HAS HAD TO REPLACE THE ON OFF SWITCH. THE DEALER MENTIONED HE HAD ONE THAT ONLY HAD 800 HOURS AND HE NEEDED TO REPLACE THE SWITCH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693399 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other