BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2393258 · Received December 30, 2011

    Report

    Report Number
    3004493922-2011-00062
    Event Type
    Malfunction
    Date Received
    December 30, 2011
    Date of Event
    December 12, 2011
    Report Date
    April 12, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #3004493922-2011-00062. THE DEVICE, CONCENTRATOR, MODEL #IRC5PO2, SERIAL # (B)(4), WAS RETURNED FOR AN EVALUATION. THE CONCENTRATOR WAS APPROXIMATELY 1 1/2 YEARS OLD AT THE TIME OF THE INCIDENT WITH NO PREVIOUS COMPLAINTS. MAINTENANCE HISTORY IS UNKNOWN. THE FILTER FOR THE ACCESS DOOR WAS MISSING. A TY WRAP FOR A CAPACITOR WAS BROKEN. THE HEPA FILTER WAS IN THE ORIGINAL CONDITION WITH NO DAMAGE SEEN. THE WAS A TOBACCO LIKE SUBSTANCE IN THE TUBING. THE CONCENTRATOR WAS FUNCTIONALLY TESTED WITH NO DISCREPANCIES NOTED. THE COMPLAINT COULD NOT BE DUPLICATED. (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 7 MONTHS OLD. THE USER MANUAL PART NUMBER 1143482 REV E (NOV-09) WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. 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 IS A (B)(6). THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC5PO, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR 7 MONTHS OLD. THE USER MANUAL PART NUMBER 1143482 REV E (NOV-09) WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMER IS A (B)(6) FEMALE, (B)(6). THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    END USER STATES THE CONCENTRATOR ALLEGEDLY GOT HOT AND SET OFF THE SMOKE DETECTORS. THE HEPA FILTER WAS ALLEGEDLY MELTED AS WELL. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    END USER STATES THE CONCENTRATOR ALLEGEDLY GOT HOT AND SET OFF THE SMOKE DETECTORS. THE HEPA FILTER WAS ALLEGEDLY MELTED AS WELL. NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 DA Other