BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3222351 · Received July 12, 2013

    Report

    Report Number
    3004493922-2013-01472
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 20, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE IRC5LX CONCENTRATOR SHUTS DOWN UNEXPECTEDLY DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321761 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE SUZHOU IRC5LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other