BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFECTO2 OXYGEN CONCENTRATOR 9153646962

    MDR report key: 5436099 · Received February 15, 2016

    Report

    Report Number
    1031452-2016-00516
    Event Type
    Injury
    Date Received
    February 15, 2016
    Date of Event
    February 6, 2016
    Report Date
    February 15, 2016
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED. USER¿S MANUAL REVIEW (1143482 REV. F, PAGE 4) DANGER - DO NOT SMOKE WHILE USING THIS DEVICE. KEEP ALL MATCHES, LIGHTED CIGARETTES OR OTHER SOURCES OF IGNITION OUT OF THE ROOM IN WHICH THIS PRODUCT IS LOCATED AND AWAY FROM WHERE OXYGEN IS BEING DELIVERED. NO SMOKING SIGNS SHOULD BE PROMINENTLY DISPLAYED. TEXTILES AND OTHER MATERIALS THAT NORMALLY WOULD NOT BURN ARE EASILY IGNITED AND BURN WITH GREAT INTENSITY IN OXYGEN ENRICHED AIR. FAILURE TO OBSERVE THIS WARNING CAN RESULT IN SEVERE FIRE, PROPERTY DAMAGE AND CAUSE PHYSICAL INJURY OR DEATH.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED. USER¿S MANUAL REVIEW (1143482 REV. F, PAGE 4) DANGER - DO NOT SMOKE WHILE USING THIS DEVICE. KEEP ALL MATCHES, LIGHTED CIGARETTES OR OTHER SOURCES OF IGNITION OUT OF THE ROOM IN WHICH THIS PRODUCT IS LOCATED AND AWAY FROM WHERE OXYGEN IS BEING DELIVERED. NO SMOKING SIGNS SHOULD BE PROMINENTLY DISPLAYED. TEXTILES AND OTHER MATERIALS THAT NORMALLY WOULD NOT BURN ARE EASILY IGNITED AND BURN WITH GREAT INTENSITY IN OXYGEN ENRICHED AIR. FAILURE TO OBSERVE THIS WARNING CAN RESULT IN SEVERE FIRE, PROPERTY DAMAGE AND CAUSE PHYSICAL INJURY OR DEATH.

    Description of Event or Problem · 1

    FILE TWO OF TWO: THE TBM CALLED. THE DEALER REPORTED TO THE TBM THAT ON THIS UNIT WAS BEING USED BY THE HUSBAND IN A ROOM WITH A BED. THE CONSUMER IS ALLEGING THE UNIT CAUGHT FIRE. THE CONSUMER IS NOT PROVIDING DETAILS TO THE DEALER. THE DEALER STATED THE FIRE DEPARTMENT IS INVESTIGATING. THE DEALER STATED THE FIRE CHIEF BELIEVES THE HUSBAND WAS DRUNK AND SMOKING IN BED. WHEN THE FIRE CHIEF SHOWED UP, HE COULD NOT FIND THE UNIT THE FIRE CHIEF STATED THE SON IN LAW WAS EVASIVE ABOUT THE CANNULA AND TUBING AND WOULD NOT PROVIDE THOSE ITEMS TO THE FIRE CHIEF. THE DEALER BELIEVES HE SHOULD HAVE THE FINDINGS FROM THE FIRE DEPARTMENT TODAY OR TOMORROW.

    Description of Event or Problem · 1

    UPDATE FROM 02/15/2016 01:14 PM ADDED BY CONSUMER AFFAIRS: EMAIL FROM DEALER STATING END USER IS REFUSING TO GIVE THE CONCENTRATOR TO THE FIRE DEPARTMENT OR DEALER. RETURN HAS BEEN REQUESTED BUT END USER IS REFUSING AT THIS TIME. FILE WILL BE UPDATED IF NEW INFORMATION BECOMES AVAILABLE. UPDATE FROM 02/15/2016 01:25 PM ADDED BY CONSUMER AFFAIRS: INVACARE ENGINEERING LOOKED AT THE CONCENTRATOR PHOTOS AND STATED THE FIRE HAD TO START FROM AN EXTERNAL SOURCE AS ALL INTERNAL COMPONENTS APPEAR TO BE IN GOOD CONDITION IN THE PICTURE. IT CANNOT BE CONFIRMED WITHOUT EXAMINING THE UNIT BUT THE PICTURES SHOW THE CAPACITOR, WIRING, AND INTERNAL COMPONENTS IN GOOD CONDITION AND EXTERIOR OF UNIT APPEARS AS THOUGH IT WAS BURNT FROM AN OUTSIDE SOURCE OR CANNULA FIRE. FURTHER INSPECTION AND EVALUATION WILL BE DONE BY ENGINEERING IF PRODUCT IS RETURNED. AT THIS TIME, END USER IS REFUSING TO RETURN UNIT. THE TBM CALLED. THE DEALER REPORTED TO THE TBM THAT ON THIS UNIT WAS BEING USED BY THE HUSBAND IN A ROOM WITH A BED. THE CONSUMER IS ALLEGING THE UNIT CAUGHT FIRE. THE CONSUMER IS NOT PROVIDING DETAILS TO THE DEALER. THE DEALER STATED THE FIRE DEPARTMENT IS INVESTIGATING. THE DEALER STATED THE FIRE CHIEF BELIEVES THE HUSBAND WAS DRUNK AND SMOKING IN BED. WHEN THE FIRE CHIEF SHOWED UP, HE COULD NOT FIND THE UNIT THE FIRE CHIEF STATED THE SON IN LAW WAS EVASIVE ABOUT THE CANNULA AND TUBING AND WOULD NOT PROVIDE THOSE ITEMS TO THE FIRE CHIEF. THE DEALER BELIEVES HE SHOULD HAVE THE FINDINGS FROM THE FIRE DEPARTMENT TODAY OR TOMORROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93208 PERFECTO2 OXYGEN CONCENTRATOR 9153646962 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5P

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization