BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4122585 · Received September 26, 2014

    Report

    Report Number
    3008262382-2014-01307
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 8, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER INDEPENDENT REPAIR CENTER, UNIT HAS LOW O2 OR YELLOW LIGHT. FAILURES INCLUDE: LEAKING AT THE HOSE CLAMPS, LEAKING AT THE ZIP TIES, AND A DIRTY PM KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600336 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other