BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2231292 · Received September 1, 2011

    Report

    Report Number
    1031452-2011-00006
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS CONCENTRATOR. THE MODEL IRC5PO2V SN (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE USER MANUAL FOR THIS DEVICE IS PART NUMBER 1143482 THE DEALER ALLEGES THAT THE DEVICE WAS RUNNING VERY HOT. THE DEVICE ALARMED [FAIL SAFE] AND SHUT OFF [FAIL SAFE] . INVACARE HAS INCORPORATED SAFETY MECHANISMS TO SHUT THE DEVICE DOWN IF OVERHEATING OCCURS. PAGE 13 OF THE USER MANUAL LISTS THEM. THE FAIL SAFES ARE 'CURRENT OVERLOAD OR LINE SURGE SHUTDOWN. HIGH TEMPERATURE COMPRESSOR SHUTDOWN. HIGH PRESSURE ALARM W/COMPRESSOR SHUTDOWN. LOW PRESSURE ALARM W/COMPRESSOR SHUTDOWN. BATTERY FREE POWER LOSS ALARM. SENSO2 OXYGEN SYSTEM (SENSO2 MODEL) LOW FLOW ALARM'. THE DEALER STATED THE DEVICE ALARMED AS EXPECTED. IN ADDITION, THE DEALER STATED THE DEVICE SHUT DOWN AS EXPECTED. SYSTEM FAILURE INDICATORS FOR INITIAL START-UP AS SHOWN ON PAGES 21 AND 22 OF THE USER'S MANUAL WERE MENTIONED BY THE DEALER. THESE INDICATORS WOULD ALERT THE DEALER/CONSUMER WITH OVERHEATING ON THE DEVICE.

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE UNIT RUNS VERY HOT, GETS A RED ALARM, AND SHUTS DOWN. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other