BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2950646 · Received February 8, 2013

    Report

    Report Number
    1525712-2013-00932
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 7, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCT. ON (B)(4) 2012, FILE # (B)(4) WAS PROCESSED, AND DETERMINED TO BE NOT REPORTABLE BECAUSE IT WAS REGARDING A CONTINUOUS ERROR MESSAGE ON THE JOYSTICK, WHICH WAS REPLACED. (B)(4) 2012, FILE # (B)(4), FOR THE SAME ISSUE, AND THE JOYSTICK WAS AGAIN REPLACED. THIS IS THE THIRD TIME THE PROVIDER REPORTS ON THIS 3GTQ3 POWER WHEELCHAIR JOYSTICK HAVING ISSUES, THIS TIME IT WAS DETERMINED TO BE REPORTABLE, AND A MDR REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(6) -THE DEALER REPORTED THAT THE 3GTQ3 POWER WHEELCHAIR MPJ JOYSTICK WAS DISPLAYING GOODBYE AND WOULD TURN ON AND OFF INTERMITTENTLY, THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54003 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GTQ3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other