BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2192400 · Received August 5, 2011

    Report

    Report Number
    1525712-2011-00421
    Date Received
    August 5, 2011
    Date of Event
    May 31, 2011
    Report Date
    August 4, 2011
    Manufacturer
    INVACARE
    Product Code
    CAW
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCENTRATOR MODEL AND SERIAL NUMBER ARE UNKNOWN. IT IS UNKNOWN IF THE DEVICE WAS THE ROOT CAUSE OF THE FIRE. IT IS UNKNOWN IF THE CONSUMER HAS READ AND UNDERSTANDS THE USER MANUAL AS DIRECTED IN OUR LABELING. ALL INVACARE CONCENTRATOR USER MANUALS PUBLISH WARNINGS TO REDUCE THE RISK OF BURNS, ELECTROCUTION, FIRE AND INJURY TO PERSONS. THE FOLLOWING IS AN EXAMPLE FOR MODEL IRC5PO2V USER MANUAL PART NO 1143482 PAGE 7: TO REDUCE THE RISK OF BURNS, ELECTROCUTION, FIRE OR INJURY TO PERSONS - DANGER: RISK OF ELECTRIC SHOCK. DO NOT DISASSEMBLE. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL. NO USER SERVICEABLE PARTS. AVOID USING WHILE BATHING. IF CONTINUOUS USAGE IS REQUIRED BY THE PHYSICIAN'S PRESCRIPTION, THE CONCENTRATOR MUST BE LOCATED IN ANOTHER ROOM AT LEAST 7 FT FROM THE BATH. DO NOT COME IN CONTACT WITH THE CONCENTRATOR WHILE WET. DO NOT PLACE OR STORE PRODUCT WHERE IT CAN DROP INTO WATER OR OTHER LIQUID. DO NOT REACH FOR PRODUCT THAT HAS FALLEN INTO WATER. UNPLUG IMMEDIATELY. IF THE CONCENTRATOR HAS A DAMAGED CORD OR PLUG, IF IT IS NOT WORKING PROPERLY, IF IT HAS BEEN DROPPED OR DAMAGED, OR DROPPED INTO WATER, CALL QUALIFIED TECHNICIAN FOR EXAMINATION AND REPAIR. A SPONTANEOUS AND VIOLENT IGNITION MAY OCCUR IF OIL, GREASE OR GREASY SUBSTANCES COME IN CONTACT WITH OXYGEN UNDER PRESSURE. THESE SUBSTANCES MUST BE KEPT AWAY FROM THE OXYGEN CONCENTRATOR, TUBING AND CONNECTIONS, AND ALL OTHER OXYGEN EQUIPMENT. DO NOT USE ANY LUBRICANTS UNLESS RECOMMENDED BY INVACARE. AVOID CREATION OF ANY SPARK NEAR MEDICAL OXYGEN EQUIPMENT. THIS INCLUDES SPARKS FROM STATIC ELECTRICITY CREATED BY ANY TYPE OF FRICTION. (B)(4) - THE DEVICE WAS NOT AN INVACARE DEVICE, AS FOUND DURING THE INVESTIGATION OF THE FIRE SITE. THE DEVICE IS AN (B)(4).

    Additional Manufacturer Narrative · 1

    THE CONCENTRATOR MODEL AND SERIAL NUMBER ARE UNKNOWN. IT IS UNKNOWN IF THE DEVICE WAS THE ROOT CAUSE OF THE FIRE. IT IS UNKNOWN IF THE CONSUMER HAS READ AND UNDERSTANDS THE USER MANUAL AS DIRECTED IN OUR LABELING. ALL INVACARE CONCENTRATOR USER MANUALS PUBLISH WARNINGS TO REDUCE THE RISK OF BURNS, ELECTROCUTION, FIRE AND INJURY TO PERSONS. THE FOLLOWING IS AN EXAMPLE FOR MODEL IRC5PO2V USER MANUAL PART NO 1143482 PAGE 7: TO REDUCE THE RISK OF BURNS, ELECTROCUTION, FIRE OR INJURY TO PERSONS _ DANGER RISK OF ELECTRIC SHOCK. DO NOT DISASSEMBLE. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL. NO USER SERVICEABLE PARTS. AVOID USING WHILE BATHING. IF CONTINUOUS USAGE IS REQUIRED BY THE PHYSICIAN'S PRESCRIPTION, THE CONCENTRATOR MUST BE LOCATED IN ANOTHER ROOM AT LEAST 7 FT FROM THE BATH. DO NOT COME IN CONTACT WITH THE CONCENTRATOR WHILE WET. DO NOT PLACE OR STORE PRODUCT WHERE IT CAN DROP INTO WATER OR OTHER LIQUID. DO NOT REACH FOR PRODUCT THAT HAS FALLEN INTO WATER. UNPLUG IMMEDIATELY. IF THE CONCENTRATOR HAS A DAMAGED CORD OR PLUG, IF IT IS NOT WORKING PROPERLY, IF IT HAS BEEN DROPPED OR DAMAGED, OR DROPPED INTO WATER, CALL QUALIFIED TECHNICIAN FOR EXAMINATION AND REPAIR. A SPONTANEOUS AND VIOLENT IGNITION MAY OCCUR IF OIL, GREASE OR GREASY SUBSTANCES COME IN CONTACT WITH OXYGEN UNDER PRESSURE. THESE SUBSTANCES MUST BE KEPT AWAY FROM THE OXYGEN CONCENTRATOR, TUBING AND CONNECTIONS, AND ALL OTHER OXYGEN EQUIPMENT. DO NOT USE ANY LUBRICANTS UNLESS RECOMMENDED BY INVACARE. AVOID CREATION OF ANY SPARK NEAR MEDICAL OXYGEN EQUIPMENT. THIS INCLUDES SPARKS FROM STATIC ELECTRICITY CREATED BY ANY TYPE OF FRICTION.

    Description of Event or Problem · 1

    THE INSURANCE COMPANY ALLEGES THAN AN INVACARE CONCENTRATOR WAS INVOLVED IN A FATAL HOUSE FIRE. NO MODEL OR SERIAL NUMBER ARE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE INSURANCE COMPANY ALLEGES THAN AN INVACARE CONCENTRATOR WAS INVOLVED IN A FATAL HOUSE FIRE. NO MODEL OR SERIAL NUMBER ARE AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1