BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2940245 · Received February 2, 2013

    Report

    Report Number
    1031452-2013-00188
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    January 31, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) THE DEALER REPORTED THAT THE IRC5PO2 STATIONARY CONCENTRATOR WOULD LOGOFF WITHOUT COMMAND, AND NOT ALARMED TO ALERT THE USER TO SEEK AN ALTERNATIVE OXYGEN SOURCE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45551 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other