BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3013771 · Received March 20, 2013

    Report

    Report Number
    1525712-2013-02103
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH FOUR DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE UNSPECIFIED CUSTOM POWER WHEELCHAIR HAD A BROKEN INDUCTIVE, AND A KINKED CABLE, POSSIBLY CAUSING THE UNIT TO INTERMITTENTLY STOP, THE JOYSTICK DISPLAYING "GOODBYE", BUT REMAINING LOGGED ON. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116766 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other