BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4041119 · Received August 27, 2014

    Report

    Report Number
    1031452-2014-07456
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    August 1, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES LOW O2. PER INDEPENDENT REPAIR CENTER STATEMENT, UNIT IS ALARMING/RED LIGHT. FAILURE MODE: INLET FILTER/DIRTY, P/E VALVE ASSEMBLY/LEAKING (KEY FAILURE), COOLING FAN/NOISY WEAK, HOSE CLAMP/REPLACED, ZIP TIE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522248 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other