BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4090136 · Received September 15, 2014

    Report

    Report Number
    1031452-2014-09321
    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
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER COMPLAINANT, 4-WAY VALVE IS CONTAMINATED, WITH A FOREIGN SUBSTANCE. PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT WAS ALARMING OR RED LIGHT. THE KEY FAILURE WAS 4-WAY VALVE IS CONTAMINATED, WITH A FOREIGN SUBSTANCE. ADDITIONAL MALFUNCTIONS WERE 02 OUTLET BROKEN, CONTROLS SHORT CIRCUIT, AND TOP SHROUD CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569832 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other