BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3972628 · Received August 1, 2014

    Report

    Report Number
    1031452-2014-04926
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AND REPAIR AT THE SERVICE CENTER, THE UNIT HAD RED LIGHT/ALARM. THIS WAS DUE TO THE MANIFOLD VALVE NOT SHIFTING CORRECTLY, WHICH LEAD TO THE MALFUNCTION.

    Description of Event or Problem · 1

    PER PROVIDER, MANIFOLD VALVE IS NOT SHIFTING FULLY. REPAIR STATEMENT INDICATES UNIT HAD RED LIGHT/ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450274 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other