BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 5015472 · Received August 19, 2015

    Report

    Report Number
    1525712-2015-04316
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Report Date
    July 27, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    TECH STATES THE PROVIDER STATES THE END USER ALLEGES THE SEAT HAS SIDE TO SIDE MOTION. UPDATE 7/27/2015 4:39PM - THE DEALER STATES THE SEAT IS WOBBLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550243 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET 3GTQ3-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other