BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 4790399 · Received May 22, 2015

    Report

    Report Number
    1525712-2015-03042
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 1, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEALER IS STATING THAT THE FOOTPLATE CLAMPS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335102 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other