BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3840858 · Received May 30, 2014

    Report

    Report Number
    1031452-2014-01819
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    June 24, 2013
    Report Date
    April 14, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER CUSTOMER THE BATTERY DOES NOT LAST 2.5 HRS ON 2; LASTS 1 HOUR 15 MIN THEN SHUTS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318098 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other