BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3974810 · Received August 4, 2014

    Report

    Report Number
    1525712-2014-04237
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    June 27, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER SAID THE USER SAID THEY COULD NOT DRIVE FORWARD OR REVERSE. DEALER SAID HE WAS ABLE TO IF HE SIP AN PUFF EXTREMELY HARD. DEALER SAID THE SETTINGS WERE .20 AND .10 FOR THE HANDS AND SOFTS. DEALER SAID HE TRIED HIS OWN STRAW AND IT DID NOT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453239 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other