BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2993572 · Received March 7, 2013

    Report

    Report Number
    1031452-2013-00498
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE UNIT HAD LOW PSI OUTPUT AND WAS SHUTTING DOWN UNEXPECTEDLY. IT IS UNKNOWN IF THE UNIT ALARMED PRIOR TO SHUTDOWN TO ALERT THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96896 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other