BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2316177 · Received October 31, 2011

    Report

    Report Number
    1031452-2011-00037
    Event Type
    Malfunction
    Date Received
    October 31, 2011
    Date of Event
    September 29, 2011
    Report Date
    May 10, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO2 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 MONTHS OLD. THIS IS AN "OUT OF BOX FAILURE". THE USER MANUAL PART NUMBER 1143482 REV E (NOV-09) WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1031452-2011-00037. THE DEVICE, CONCENTRATOR, MODEL #IRC5PO2, SERIAL #(B)(4) WAS RETURNED FOR AN INSPECTION. THE PRODUCT WAS APPROXIMATELY 2 MONTHS OLD AT TIME OF COMPLAINT. THE MAINTENANCE HISTORY IS UNKNOWN AT TIME OF THE COMPLAINT. THE ACCESS DOOR WAS NOT ATTACHED WHEN PRODUCT WAS RETURNED. THE CONCENTRATOR WAS TURNED ON AND SET TO 5 LPM. IT WAS RUN FOR 2 HOURS AND IT DID NOT GET HOT. NO PROBLEMS WERE FOUND. THE PRODUCT DID NOT GET HOT. THIS DEVICE IS USED FOR TREATMENT BUT NOT DIAGNOSIS. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO2 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 MONTHS OLD. THIS IS AN "OUT OF BOX FAILURE". THE USER MANUAL PART NUMBER 1143482 REV E (NOV-09) WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    AFTER DEALER DELIVERED CONCENTRATOR TO END USER, IT ALLEGEDLY OVERHEATED IMMEDIATELY AND WAS VERY HOT TO THE TOUCH. DEALER PICKED UP CONCENTRATOR AND TOOK IT BACK TO THE SHOP. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    AFTER DEALER DELIVERED CONCENTRATOR TO END USER, IT ALLEGEDLY OVERHEATED IMMEDIATELY AND WAS VERY HOT TO THE TOUCH. DEALER PICKED UP CONCENTRATOR AND TOOK IT BACK TO THE SHOP. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) 868.5440 CAW INVACARE FLORIDA OPERATIONS IRC5PO2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other