BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2233918 · Received September 6, 2011

    Report

    Report Number
    1031452-2011-00007
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 9, 2011
    Report Date
    September 2, 2011
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS CONCENTRATOR. THE MODEL IRC5PO2V SN (B)(4) IS APPROXIMATELY 10 MONTHS OLD. THE USER MANUAL FOR THIS DEVICE IS PART NUMBER 1143482. THE DEALER ALLEGES THAT THE DEVICE WAS OVERHEATING "OUT OF THE BOX". THE DEVICE ALARMED [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. (B)(4) - DEVICE EVALUATION - CONDITION OF RETURN: THE UNIT APPEARED TO BE IN GOOD CONDITION WITH 13.8 HOURS SHOWING ON THE HOUR METER. RESULT ANALYSIS: VISUAL:THE UNIT APPEARED LIKE NEW. FUNCTIONAL: THE CONCENTRATOR WAS POWERED ON AND THE FLOWMETER SET A 5LPM. AFTER APPROXIMATELY 1.5 HOURS OF OPERATION, ALTHOUGH THE O2=95%, THE SHROUD FELT WARM TO THE TOUCH AND ALARMED. THE UNIT WAS TURNED OFF AND THE SHROUD REMOVED. IT WAS DETERMINED THAT THE FAN WIRE HARNESS FROM THE PCB WAS MAKING AN INTERMITTENT CONNECTION DUE TO A DEFECT IN THE FEMALE TERMINAL OF THE CONNECTOR. THE INTERNAL CONNECTION WAS FIXED AND THE UNIT OPERATED FOR APPROXIMATELY AN HOUR WITH NO ALARMS AND THE SHROUD WAS NOT WARM. CONCLUSION: THE CONCENTRATOR MALFUNCTIONED DUE TO A DEFECT IN THE MOLEX CONNECTOR. A STEP HAS BEEN ADDED IN THE MANUFACTURING PROCESS TO USE A PERMANENT MARKER ON FAN WHEN THE UNIT IS POWERED ON TO TEST. I.E. IF FAN WORKS AND ROTATES, THE MARKER WILL MAKE A WHITE CIRCLE THAT IS CLEARLY VISIBLE. THIS CHANGE WAS EFFECTIVE (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS CONCENTRATOR. THE MODEL IRC5PO2V SN (B)(4) IS APPROXIMATELY 10 MONTHS OLD. THE USER MANUAL FOR THIS DEVICE IS PART NUMBER 1143482 THE DEALER ALLEGES THAT THE DEVICE WAS OVERHEATING "OUT OF THE BOX." THE DEVICE ALARMED [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 WAS TESTING THIS UNIT BEFORE THEY PUT IT OUT ON A NEW PATIENT. THE DEALER ALLEGES THIS IS A NEW OUT OF BOX FAILURE. THE UNIT WAS RUNNING DURING TESTING AND ALLEGEDLY OVERHEATED AND ALARMED. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE DEALER WAS TESTING THIS UNIT BEFORE THEY PUT IT OUT ON A NEW PATIENT. THE DEALER ALLEGES THIS IS A NEW OUT OF BOX FAILURE. THE UNIT WAS RUNNING DURING TESTING AND ALLEGEDLY OVERHEATED AND ALARMED. 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