BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2973256 · Received February 21, 2013

    Report

    Report Number
    3004493922-2013-00429
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE M41SR20R POWER WHEELCHAIR WAS VEERING TO THE RIGHT WHEN END USER WAS DRIVING IN A STRAIGHT PATTERN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76195 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SR20R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other