BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3935213 · Received July 15, 2014

    Report

    Report Number
    1031452-2014-03541
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 9, 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

    THE DEALER REPORTED THAT THE UNIT WAS LOUD, SHAKING AND SHUTS DOWN. AFTER I CONTACTED THE CUSTOMER VIA PHONE TODAY, THE CUSTOMER IS REPORTING THE UNIT HAS A RED LIGHT AND ALARMS CUSTOMER FIRST RECEIVED (B)(6), 2014 AND TRIED SEVERAL TIMES AND THEN WENT INTO THE HOSPITAL FOR AWHILE AND THEN TRIED AGAIN WITH SAME RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412659 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other