BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 4883304 · Received July 1, 2015

    Report

    Report Number
    1525712-2015-03651
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 29, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE NEW RIGHT MOTOR IS JERKY AND LOUD AND THE JERKING MOTION IS MAKING THE CHAIR DIFFICULT TO CONTROL.

    Description of Event or Problem · 1

    THE NEW RIGHT MOTOR IS JERKY AND LOUD AND THE JER KING MOTION IS MAKING THE CHAIR DIFFICULT TO CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424907 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET FDX-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other