BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4100042 · Received September 18, 2014

    Report

    Report Number
    1031452-2014-10010
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    August 27, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577801 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other