BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3033938 · Received April 3, 2013

    Report

    Report Number
    1525712-2013-02539
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE FACILITY STAFF THAT THE SOLARA3G CUSTOM MECHANICAL WHEELCHAIR WHEEL LOCK BRACKETS WERE ALLOWING THE BOLTS TO BACKUP, AND THE WHEEL LOCK TO FALL OFF THE UNIT. ADDITIONALLY, IT WAS REPORTED THAT A TOTAL OF FOUR SOLARA3G EXPERIENCED SIMILAR ISSUES, AND FOUR SEPARATE REPORTS WILL BE CREATED AND SUBMITTED. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137475 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other