BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2921384 · Received January 17, 2013

    Report

    Report Number
    1031452-2013-00109
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) - IT WAS REPORTED BY THE CONSUMER THAT THE XPO100B PORTABLE CONCENTRATOR WOULD INTERMITTENTLY LOGOFF AFTER LOGIN FOR ABOUT SECONDS, ALTHOUGH, THE BATTERY WAS FULLY CHARGED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25926 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other