BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3943224 · Received July 18, 2014

    Report

    Report Number
    1525712-2014-03786
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 13, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER SPOKE WITH (B)(6) IN TECH SERVICES EXT (B)(4) TO ADVISE THAT THE CHAIR IS GETTING A 3 FLASH ERROR CODE WHICH IS THE RIGHT MOTOR: NO OUTPUT. PROVIDER ADVISED TECH SERVICES THAT HE SWITCHED THE LEADS AND THE LIGHTS CONTINUED TO FLASH 3 TIMES. PROVIDER HUNG UP BEFORE ANY ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421405 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M71

    Patients

    Seq Age Sex Outcome Treatment
    1 Other