BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4120331 · Received September 26, 2014

    Report

    Report Number
    1031452-2014-11027
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    June 3, 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

    PER INDEPENDENT REPAIR CENTER STATEMENT THE UNIT HAD LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS THE REGULATOR ON THE PRODUCT TANK WAS LEAKING. ADDITIONAL MALFUNCTIONS INCLUDE THE TIE WRAP FOR THE PRODUCT TANK WERE LEAKING, THE INLET FILTER FOR THE SOUND BOX WAS DIRTY, AND THE CABINET FILTER WAS DIRTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601657 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other