BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL CHAIR/TRANSPORT CHAIR

    MDR report key: 3123125 · Received May 21, 2013

    Report

    Report Number
    1525712-2013-03991
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 24, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THE RECLINING MECHANISM ON A SOLARA3G MANUAL TILT IN SPACE WHEELCHAIR IS BROKEN. SCREW/BOLT THAT ANCHORS THE LOSHEAR BACK FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224959 MECHANICAL CHAIR/TRANSPORT CHAIR 890.3100 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other