BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2832704 · Received November 14, 2012

    Report

    Report Number
    1525712-2012-02140
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    November 8, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE UNKNOWN PRONTO POWER WHEELCHAIR MODEL AND SERIAL NUMBERS, GOT THE JOYSTICK CABLE BROKEN / DETACHED. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS NO RECENT INCIDENT INVOLVING THE UNIT, AND NO PATIENT INJURY TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN UNKNOWN PRONTO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other