BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 2771499 · Received October 4, 2012

    Report

    Report Number
    3004493922-2012-00385
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Report Date
    October 3, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS COMPLAINT ELEVATED DUE TO RMA INSPECTION. MODELIRC1705, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 1 YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1148073, REV.B(DEC-08), 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 SAMPLE HAS BEEN RECEIVED AND A SUPPLEMENTAL REPORT WILL BE SENT WHEN EVALUATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    THE AC CORD HAS A BURNT, MELTED PLUG. NO INJURY. VISUALLY DETECTED UPON INSPECTION OF THE DEVICE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE SUZHOU IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other