BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 4956954 · Received July 31, 2015

    Report

    Report Number
    9616091-2015-01955
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Report Date
    July 8, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 IS STATING THAT THE WHEELS ARE NOT STAYING ON THE CHAIR. APPEARS THAT THE AXLE BOLTS MIGHT BE ELONGATED. DEALER ALSO STATED THAT THE PUSH PIN ON THE FRONT RIGGING IS BROKEN OFF, AND THAT THE CHAIR IS MISSING 2 HEAD TUBE ARE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501919 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other