BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9XT SWINGAWAY FRAME STYLE 9153629153

    MDR report key: 4998977 · Received August 13, 2015

    Report

    Report Number
    9616091-2015-02052
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Report Date
    July 21, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED WAS ISSUED AND THE PRODUCT IS AWAITING RECEIPT AND/OR EVALUATION. A FOLLOW UP WILL BE FILED IF/WHEN ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    BRAND NEW OUT OF BOX FAILURE. THE CHAIR CAME IN, NO DAMAGE TO THE BOX, BUT THE FRAME WAS TWEAKED AND WILL NOT SIT LEVEL. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532980 9XT SWINGAWAY FRAME STYLE 9153629153 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other