BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4103320 · Received September 19, 2014

    Report

    Report Number
    1031452-2014-10149
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    August 29, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REPAIR CENTER ALLEGED THAT THE UNIT IS ALARMING/RED LIGHT AND KEY IS THE VALVE IS NOT SHIFTING. PER INDEPENDENT REPAIR STATEMENT THE UNIT WAS ALARMING OR RED LIGHT. KEY FAILURE WAS THE PILOT VALVE WAS NOT SHIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583703 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other