BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 5101112 · Received September 24, 2015

    Report

    Report Number
    9616091-2015-02320
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    August 27, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DEALER STATED, THE CYCLICAL LEVER DRIVE WAS SLIPPING AND WAS NOT ENGAGING THE WHEEL LOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632854 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1