BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3092883 · Received May 3, 2013

    Report

    Report Number
    1031452-2013-00842
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH AN XPO100B PORTABLE CONCENTRATOR SHUTTING DOWN. IT IS UNKNOWN IF THE UNIT ALARMED, AS DESIGNED, PRIOR TO SHUTDOWN TO ALERT THE USER TO SWITCH TO AN ALTERNATE SOURCE OF OXYGEN AND TO SEEK REPAIRS. THIS IS NOT A LIFE SUPPORT/SUSTAINING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195311 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other