BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2841056 · Received November 20, 2012

    Report

    Report Number
    1031452-2012-00282
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    November 17, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MODEL IRC10LX, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1118353, REV J (APR-09) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. INVACARE IS IN PROCESS OF GATHERING ADDITIONAL INFORMATION. A SUPPLEMENTAL REPORT WILL BE FILED WITH ANY FURTHER INFORMATION THAT IS RECEIVED.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REPORTING THE CONCENTRATOR STOPPED WORKING WHILE THE PATIENT WAS ASLEEP. THE ALARM WAS NOT HEARD. THE END USER WOKE UP IN DISTRESS AND WAS TAKEN TO THE ER AND RELEASED THE SAME DAY. THE DEALER STATES THAT THE CONCENTRATOR WAS NOT IN THE SAME ROOM AS THE PATIENT. THE DEALER STATES THEY HAVE REPLACED THE UNIT AND ADVISED THE PATIENT TO KEEP THE UNIT IN THE SAME ROOM.

    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 Hospitalization| O| R