BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3974769 · Received August 4, 2014

    Report

    Report Number
    1031452-2014-04922
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    June 20, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING AND REPAIR AT THE SERVICE CENTER, THE DEVICE ALARMED FOR LOW O2. THIS WAS DUE TO THE MANIFOLD GEAR CLAMP BEING LOOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEAR CLAMP IS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455367 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other