BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4213456 · Received October 30, 2014

    Report

    Report Number
    1525712-2014-07454
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 13, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER REPORTING THAT RECENTLY THEY HAD WORK DONE ON THE CHAIR BY NUMOTION. THEY ARE UNHAPPY WITH THE QUALITY OF THE WORK THAT WAS DONE. THEY ARE STATING THAT THE BATTERY STRAPS ARE NOT HOLDING THE BATTERY DOWN AND THAT THE TECHNICIAN STUFFED SOME SORT OF PAPER DOWN IN THE UNIT TO HOLD THE BATTERIES IN. THEY ALSO REQUESTING TO HAVE THE BEARINGS REPLACED IN THE CHAIR, AND THEY ARE STATING THE BEARINGS LOOK AND FEEL UNTOUCHED BASED ON HOW THE CHAIR IS RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695354 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other