BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3131666 · Received May 29, 2013

    Report

    Report Number
    9616091-2013-00900
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    December 11, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUAL WHEELCHAIR INVACARE AWARENESS DATE ((B)(4) 2012). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FROM CUSTOMER SERVICE FOR PROCESSING UNTIL ((B)(4) 2013). POTENTIAL FOR INJURY ASSOCIATED WITH THE FRONT RIGGINGS ON A 9TPZ MANUAL WHEELCHAIR BEING LOCKED UP, NOT MOVING. THIS COULD CAUSE THE END USER TO NOT BE ABLE TO GET OUT OF THE CHAIR.

    Description of Event or Problem · 1

    PROVIDER STATES ONCE THE LEGS ARE ELEVATED THEY WILL NOT RELEASE TO COME BACK DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234160 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9TPZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other