BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4093338 · Received September 16, 2014

    Report

    Report Number
    1031452-2014-09515
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 25, 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

    PROVIDER ALLEGED THE MANIFOLD VALVE IS DEFECTIVE. PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT WAS LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS MANIFOLD VALVE WAS LEAKING. ADDITIONAL MALFUNCTIONS WERE CASTER ON BASE IS MISSING, TIE STRAP ON SIEVE BEDS IS DEFECTIVE, VALVE/MANIFOLD IS DEFECTIVE, CLAMP ON MANIFOLD ASSEMBLY IS DEFECTIVE, TY WRAP ON MANIFOLD ASSEMBLY IS DEFECTIVE, PC BOARD ON CONTROL PANEL IS DEFECTIVE, TIE STRAP ON PRODUCT TANK IS DEFECTIVE AND HEAT EXCHANGER IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570902 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other