BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    MDR report key: 2648294 · Received July 10, 2012

    Report

    Report Number
    1031452-2012-00111
    Event Type
    Malfunction
    Date Received
    July 10, 2012
    Report Date
    July 17, 2012
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1031452-2012-00111 LISTING THE MODEL # AS IRC50P. THE CORRECT MODEL # IS IRC5PO2. (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC50P, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143482 REV E (NOV-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. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. DEALER ALLEGES THAT THE POWER CORD HAD DAMAGE UNDER DUCK TAPE WHEN RETURNED FROM CUSTOMER AND DURING REMOVAL OF POWER CORD THE RELIEF STRAIN BROKE. WARRANTY REPLACEMENT PARTS WERE ORDERED.

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IRC50P, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 4 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143482 REV E (NOV-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. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. DEALER ALLEGES THAT THE POWER CORD HAD DAMAGE UNDER DUCK TAPE WHEN RETURNED FROM CUSTOMER AND DURING REMOVAL OF POWER CORD, THE RELIEF STRAIN BROKE. WARRANTY REPLACEMENT PARTS WERE ORDERED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE POWER CORD HAD DAMAGE UNDER DUCT TAPE. QT (B)(4), ORDER #(B)(4). NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE POWER CORD HAD DAMAGE UNDER DUCT TAPE. QT (B)(4), ORDER # (B)(4). 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