BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4062641 · Received September 5, 2014

    Report

    Report Number
    9616091-2014-01765
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Report Date
    August 13, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE WHEEL LOCKS ON THESE CHAIRS WITH THE SPECIAL (B)(4) HAVE THE CLAMP ON WHEEL LOCKS, AND THAT THIS STYLE OF WHEEL LOCK IS BENDING. HE WAS CALLING TO INQUIRE ABOUT PUTTING PIVOT/LINK STYLE WHEEL LOCKS ON THE CHAIRS. INVESTIGATING WITH SPECIALS AT INVAMEX TO SEE IF THIS WILL BE EFFECTIVE. (B)(6) 2014- INVAMEX STATES THEY CANNOT USE PIVOT STYLE LINKS FOR THESE CHAIR SINCE THEY WILL NOT REACH THE REAR WHEEL PROPERLY CUSTOMER HAS BEEN ADVISED THAT THIS WILL NOT BE COVERED BY WARRANTY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546034 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other