BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 4211235 · Received October 29, 2014

    Report

    Report Number
    3008262382-2014-01744
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 7, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    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, THE UNIT HAD LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS THE REGULATOR TO THE PRODUCT TANK LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692022 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE REHABILITATION EQUIP IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other