BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2262788 · Received September 24, 2011

    Report

    Report Number
    1031452-2011-00013
    Event Type
    Death
    Date Received
    September 24, 2011
    Date of Event
    August 27, 2011
    Report Date
    March 29, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012 - FOLLOW-UP #001. INITIAL (B)(4) ISSUED UF/IMPORTER REPORT #1031452-2011-00013. DEVICE MODEL #IRC10LX, SERIAL #(B)(4)WAS RETURNED FOR AN EVALUATION. THE UNIT WAS TESTED AND NO PROBLEM WAS FOUND. THE UNIT TESTED TO SPECIFICATIONS. RMA (B)(4) WAS ISSUED FOR THE RETURN OF THIS DEVICE. MODEL IRC10LX SERIAL NUMBER (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THERE IS NO ALLEGATION OF MALFUNCTION WITH THIS DEVICE. THE USER MANUAL FOR THIS DEVICE IS PART NUMBER 1118353 REV J (APR-09). IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNDERSTOOD THE USER MANUAL. ON PAGE 2 THE FOLLOWING WARNING IS PROVIDED: "WARNING DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. THE CONSUMER MOVED FROM (B)(6) TO (B)(6) ELEVATION 6500 FT. ON PAGE 13, THE FOLLOWING PARAMETERS ARE PROVIDED FOR THE ACCEPTABLE ALTITUDE WHEN USING THE DEVICE. (B)(6) IS OUTSIDE THE MAXIMUM ALLOWABLE ALTITUDE. "PARAMETERS - ALTITUDE:" "PLATINUM 5 AND XL - UP TO 6,000 FT (1828 METERS) ABOVE SEA LEVEL WITHOUT DEGRADATION OF CONCENTRATION LEVELS. FROM 6,000 FT (1828 METERS) TO 13,129 FT (4000 METERS) BELOW 90% EFFICIENCY." "PLATINUM 10 - UP TO 4,000 FT (1230 METERS) ABOVE SEA LEVEL WITHOUT DEGRADATION OF CONCENTRATION LEVELS. FROM 4,000 FT (1230 METERS) TO 13,129 FT (4000 METERS) BELOW 90% EFFICIENCY."

    Additional Manufacturer Narrative · 1

    RMA (B)(4) WAS ISSUED FOR THE RETURN OF THIS DEVICE. MODEL IRC10LX, SERIAL NUMBER (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THERE IS NO ALLEGATION OF MALFUNCTION WITH THIS DEVICE. THE USER MANUAL FOR THIS DEVICE IS PART NUMBER 1118353 REV J (APR-09). IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNDERSTOOD THE USER MANUAL. ON PAGE 2 THE FOLLOWING WARNING IS PROVIDED: "WARNING DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. THE CONSUMER MOVED FROM (B)(6). ON PAGE 13 THE FOLLOWING PARAMETERS ARE PROVIDED FOR THE ACCEPTABLE ALTITUDE WHEN USING THE DEVICE. (B)(6) IS OUTSIDE THE MAXIMUM ALLOWABLE ALTITUDE. "PARAMETERS - ALTITUDE:" "PLATINUM 5 AND XL - UP TO 6,000 FT (1828 METERS) ABOVE SEA LEVEL WITHOUT DEGRADATION OF CONCENTRATION LEVELS. FROM 6,000 FT (1828 METERS) TO 13,129 FT (4000 METERS) BELOW 90% EFFICIENCY " "PLATINUM 10 - UP TO 4,000 FT (1230 METERS) ABOVE SEA LEVEL WITHOUT DEGRADATION OF CONCENTRATION LEVELS. FROM 4,000 FT (1230 METERS) TO 13,129 FT (4000 METERS) BELOW 90% EFFICIENCY"

    Description of Event or Problem · 1

    THE CONSUMER ALLEGEDLY PASSED AWAY WHILE HE WAS SLEEPING. THE CONCENTRATOR IS NOT SUSPECTED TO HAVE PLAYED A PART IN THE DEATH. THE CONSUMER RECENTLY MOVED FROM (B)(6) TO A 6500 FOOT ELEVATION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGEDLY PASSED AWAY WHILE HE WAS SLEEPING. THE CONCENTRATOR IS NOT SUSPECTED TO HAVE PLAYED A PART IN THE DEATH. THE CONSUMER RECENTLY MOVED FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC10LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death