BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3062133 · Received April 16, 2013

    Report

    Report Number
    1525712-2013-02916
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH FIVE DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE TDXSI-2-S CUSTOM POWER WHEELCHAIR WAS VEERING TO THE LEFT. THE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163681 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSI-2-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other