BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3984575 · Received August 6, 2014

    Report

    Report Number
    1525712-2014-04443
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 7, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, CALLED IN STATED HE IS GETTING A FAULTY ERROR CODE THROUGH THE CONTROLLER FOR THE BATTERIES VOLTAGE AND THE MOTOR IS OVER HEATING. PER TECH, REPLACE CONTROLLER FOR THE FALSE READING AND THE MOTOR ISSUE IS DUE TO THE CONTROLLER SENDING OFF TOO MUCH POWER THROUGH THE BATTERY TO THE LEFT MOTOR. DEALER STATED THERE WERE NO INJURIES NOR ANY ISSUES OF ABANDONMENT ASSOCIATED WITH THE INCIDENT. DEALER STATED THE END USER IS CURRENTLY IN A NURSING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460341 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PSEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other