BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMO 1 CROSSFIRE T7A

    MDR report key: 4844872 · Received June 15, 2015

    Report

    Report Number
    1525712-2015-03425
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    May 22, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 STATES THE BASE FRAME IS BROKEN ON THE RIGHT SIDE WHERE THE BOLT GOES THROUGH TO THE SEAT FRAME AT THE TAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388224 DEMO 1 CROSSFIRE T7A WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET CT7A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other