BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4090861 · Received September 15, 2014

    Report

    Report Number
    1031452-2014-09363
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 21, 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

    IT WAS REPORTED BY THE PROVIDER THAT THE PILOT VALVE IS NOT SHIFTING. INDEPENDENT REPAIR STATEMENT CONFIRMS THIS AS THE KEY FAILURE. ALSO, THE UNIT IS ALARMING/RED LIGHT AND A TIE WRAP WAS FOUND TO BE LEAKING. NO PATIENT INJURY ALLEGED, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568698 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other