BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3071921 · Received April 22, 2013

    Report

    Report Number
    1525712-2013-03152
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER ALLEGES THAT WHILE USING CHAIR IT WILL JUST STOP AND LIGHTS START FLASHING CONSTANTLY, 5-6 TIMES A DAY, TO GET GOING WILL REBOOT SYSTEM MULTIPLE TIMES. END USER ADV THAT YESTERDAY HE WAS ON A SLIGHT DECLINE AND THE CHAIR FLASHED YELLOW, LOCKED UP AND CAME TO A DEAD STOP. WHEN THAT HAPPENED THE END USER WAS THROWN FROM THE CHAIR. HE ADV HE HAS SEEN A DOCTOR, NO INJURIES, BUT HE IS SORE. END USER ADV HE HAS HAD CHAIR SERVICED, AND THEY ARE UNABLE TO FIGURE OUT THE PROBLEM. END USER ADV HE HAS UPGRADED BATTERIES AND THE PROBLEM STILL PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172909 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GAR

    Patients

    Seq Age Sex Outcome Treatment
    1 56 Other