BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 3954419 · Received July 24, 2014

    Report

    Report Number
    1031452-2014-04250
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER (B)(4), CUSTOMER STATES THERE WAS A POWER OUTAGE AND NOW THE UNIT ONLY COMES ON AND GOES TO THE RED LIGHT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434430 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IOH200PV95PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other