BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2893605 · Received January 2, 2013

    Report

    Report Number
    1525712-2013-00017
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RMA HAS BEEN INITIATED FOR THIS ISSUE. , SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY OLD. ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH THREE DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE NUMBERS ARE THE FOLLOWING: (B)(4). THE EVENT WAS REPORTED ON TWO DIFFERENT DATES ((B)(6) 2012). HOWEVER, IT IS IN REFERENCE TO THE SAME PRODUCT, AND SAME ISSUES IN NEED OF VARIOUS PARTS TO BE REPAIRED. THEREFORE, ALL REPORTS WILL BE COMBINE, AND REPORTED ONCE. THE OWNER'S MANUAL PART NUMBER 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 AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(6) -THE DEALER REPORTED THAT THE TDXSP-MCG POWER WHEELCHAIR WOULD RANDOMLY GO INTO DRIVE LOCKOUT WITHOUT COMMAND. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other