BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2955928 · Received February 11, 2013

    Report

    Report Number
    1525712-2013-01036
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE TERRITORY BUSINESS MANAGER THAT THE PRONTO M61 POWER WHEELCHAIR WOULD LOGOFF EVERY TIME GOING OVER A BUMP. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59495 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M61

    Patients

    Seq Age Sex Outcome Treatment
    1 Other