BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2993413 · Received March 7, 2013

    Report

    Report Number
    1031452-2013-00493
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE UNIT SHUTS DOWN UNEXPECTEDLY AND IS MAKING A LOUD NOISE BOTH WHILE USING BATTER POWER AND A/C POWER. IT IS UNKNOWN IF THE UNIT ALARMED PRIOR TO SHUTTING DOWN TO ALERT THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96834 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS XPO100B

    Patients

    Seq Age Sex Outcome Treatment
    1 75 Other