BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 5013835 · Received August 19, 2015

    Report

    Report Number
    9616091-2015-02091
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Report Date
    July 24, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    DEALER IS STATING THAT THE WHEEL LOCK ARE NOT WORKING. THEY WILL NOT ENGAGE AND THE WHEEL LOCKS ARE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550213 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other