BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2568665 · Received May 10, 2012

    Report

    Report Number
    1525712-2012-00539
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Report Date
    May 9, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA ISSUED FOR THIS EVENT. MODEL NUMBER 3GTQ-CG (B)(4) IS APPROXIMATELY 1 YEAR AND 7 MONTHS OF AGE. USER MANUAL PART NUMBER 1143151 REV H (JUL-10) WAS ISSUED WITH THIS DEVICE. IT IS UNKNOWN IF THE USER HAS READ AND FULLY UNDERSTANDS THE USER MANUAL. THE CONSUMERS MEDICATION CONDITION, STABILITY, AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS AGE, WEIGHT, AND HEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE DEALER ALLEGES THAT THE BOLTS ON THE DRIVE WHEEL BACKED OUT OVER TIME ON THEIR OWN, BUT NO PATIENT INJURY OR PROPERTY DAMAGE WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES BOLTS ON DRIVE WHEEL BACKED OUT OVER TIME. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ-CO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other