BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3964296 · Received July 29, 2014

    Report

    Report Number
    3008262382-2014-00398
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2014 THE JOYSTICK EXTENSION CABLE WAS REPLACED FOR THE M41SRB POWER CHAIR. END USER REPORTS HAVING PROBLEMS WITH CHAIR SLOWING DOWN AFTER THE REPLACEMENT. SHE REPORTS NO PROBLEMS UP UNTIL THIS POINT. ON (B)(6), THE DEALER REPLACED THE JOYSTICK EXTENSION CABLE AGAIN PER THE RECALL LETTER. THE END USER NOTICED A HESITATION THE SAME DAY, BUT TOOK THE CHAIR OUT ON FRIDAY. THE CHAIR STOPPED DEAD IN THE MIDDLE OF THE STREET AND END USER CLAIMS SHE WAS ALMOST HIT BY A CAR. SHE WAS ABLE TO START IT AGAIN AFTER TURNING OFF THE JOYSTICK AND TURNING IT BACK ON. SHE STATES NOW THE LEGREST IS RUBBING AGAINST THE SIDE OF THE CHAIR DUE TO THE ABRUPT STOP. SHE WAS COMPLAINING OF BACK PAIN DUE TO THE ABRUPT STOP. SHE ADDED LATER THAT THE CONTROLLER WAS VERY HOT WHERE THE JOYSTICK EXTENSION CABLE PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442285 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 Other