BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2940276 · Received February 2, 2013

    Report

    Report Number
    1525712-2013-00739
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    February 1, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE IVC TERRITORY BUSINESS MANAGER THAT THE FDX-MCG POWER WHEELCHAIR SEAT WAS CRACKED AND TILTED, CAUSING THE USER TO SLIDE DOWN AND OFF THE UNIT. ADDITIONALLY, WRONG HARDWARE AND BACK CUSHION WAS SENT IN ERROR. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45704 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other