BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2040191 · Received March 24, 2011

    Report

    Report Number
    1525712-2011-00138
    Event Type
    Other
    Date Received
    March 24, 2011
    Date of Event
    March 4, 2011
    Report Date
    May 10, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCENTRATOR REPORTEDLY RAN A FEW HOURS THEN ALARMED AND IS REPORTED AS HOT. THE CONCENTRATOR HAS VARIOUS SERVICE ALARMS AND SAFETY FEATURES. THERE IS A HIGH TEMPERATURE COMPRESSOR SHUTDOWN FEATURE. IF THE COOLING FAN HAS BECOME DAMAGED IN TRANSPORT OR HANDLING THE CONCENTRATOR WILL ALARM. MANUFACTURER IS WORKING TO OBTAIN PRODUCT FOR INSPECTION. MDR FILED BASED ON STATEMENT THE DEVICE BECAME HOT.

    Additional Manufacturer Narrative · 1

    INITIAL (B)(4) ISSUED MFG. REPORT #1525712-2011-00138. THE DEVICE, CONCENTRATOR, MODEL #IRC5PO2V, SERIAL #(B)(4) WAS RETURNED FOR AN INSPECTION. THE DEVICE WAS ABOUT A MONTH OLD AND HAD 5.5 HOURS OF RUNNING TIME. THE CONCENTRATOR WAS POWERED ON AND SET AT 5LPM. THE OXYGEN RAN AT O2=94.6%. AFTER AN INSPECTION OF THE INTERNAL COMPONENTS, IT WAS FOUND THAT THE WIRE CONNECTING THE FAN WAS NOT CONNECTED. A CHECK WAS ADDED IN THE MANUFACTURING PROCESS TO ENSURE THAT THE WIRING WOULD STAY CONNECTED AND IS DOCUMENTED IN (B)(4). THIS DEVICE IS USED FOR TREATMENT BUT NOT DIAGNOSIS. (B)(4). THE CONCENTRATOR REPORTEDLY RAN A FEW HOURS THEN ALARMED AND IS REPORTED AS HOT. THE CONCENTRATOR HAS VARIOUS SERVICE ALARMS AND SAFETY FEATURES. THERE IS A HIGH TEMPERATURE COMPRESSOR SHUTDOWN FEATURE. IF THE COOLING FAN HAS BECOME DAMAGED IN TRANSPORT OR HANDLING THE CONCENTRATOR WILL ALARM. MANUFACTURE IS WORKING TO OBTAIN PRODUCT FOR INSPECTION. MDR FILED BASED ON STATEMENT THE DEVICE BECAME HOT.

    Description of Event or Problem · 1

    THE UNIT RAN FOR A FEW HOURS AND THEN ALL THE LIGHTS CAME ON AND THE UNIT BECAME VERY HOT. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE UNIT RAN FOR A FEW HOURS AND THEN ALL THE LIGHTS CAME ON AND THE UNIT BECAME VERY HOT. 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