BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3243484 · Received July 23, 2013

    Report

    Report Number
    1031452-2013-01441
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 3, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THIS REPORT IS FOLLOW UP 001 TO COMPLETE THE INFORMATION IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A IRC10LXO2 CONCENTRATOR WAS SHUTTING DOWN BY ITSELF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A IRC10LXO2 CONCENTRATOR WAS SHUTTING DOWN BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343191 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other