BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2586507 · Received May 24, 2012

    Report

    Report Number
    1525712-2012-00632
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Report Date
    May 23, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TDXSP, (B)(4) IS APPROXIMATELY 2 YEARS 6 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1143190 RE G (JAN-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 IS A (B)(6) MALE WHO (B)(6). THE CONSUMERS PREEXISTING MEDICAL CONDITION STATES THAT HE IS A DOUBLE AMPUTEE. THE CONSUMERS MEDICATION REGIMEN IS UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMER STATED THAT HE WAS GETTING STUCK IN THE TILT POSITION. HE STATED THAT HE HAS NOT HAD HIS CHAIR SINCE (B)(6) 2012 & IS USING A MANUAL LOANER CHAIR FROM HIS APARTMENT BUILDING. THE DEALER STATED THAT THEY PREVIOUSLY REPLACED THE JOYSTICK DUE TO A SOFTWARE GLITCH AND A MOTOR DUE TO WATER DAMAGE. BOTH THESE ITEMS WERE COVERED UNDER WARRANTY. THE DEALER STATED THAT THIS CURRENT JOYSTICK ISSUE APPEARS TO INDICATE THAT IT WAS RUN INTO A COUNTER AS THERE IS INTERNAL DAMAGE TO THE JOYSTICK. THE CONSUMER ALLEGEDLY CHOOSES TO GO THROUGH INSURANCE FOR PAYMENT. THE DEALER STATED THAT THEY JUST RECEIVED THE LMN (LETTER OF MEDICAL NECESSITY), MEDICARE TAKES 4-16 WEEKS TO MAKE A DECISION. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES HE WAS GETTING STUCK IN THE TILT BACK POSITION. NO INJURY ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 Other