BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 5042553 · Received August 31, 2015

    Report

    Report Number
    1525712-2015-04419
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Report Date
    January 5, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: CUSTOM POWER WHEELCHAIRS. CONTROLLER/JOYSTICK/OPTIONS, PC BOARD FAILURE. NOT HOLDING TIME/DATE, 3.3VOLTS ON BATTERY. COMPLAINT WAS CONFIRMED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED AFTER REVIEWING THE DOCUMENTATION IN THIS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: CUSTOM POWER WHEELCHAIRS. CONTROLLER/JOYSTICK/OPTIONS, PC BOARD FAILURE. NOT HOLDING TIME/DATE, 3.3VOLTS ON BATTERY. DEALER STATES THAT THE JOYSTICK IS CUTTING OUT GOES TO A BLANK SCREEN. AND THE PATIENT STATED THAT IF LEFT ALONE FOR A WHILE IT WILL TURN BACK ON.

    Description of Event or Problem · 1

    DEALER STATES THAT THE JOYSTICK IS CUTTING OUT GOES TO A BLANK SCREEN. AND THE PATIENT STATED THAT IF LEFT ALONE FOR A WHILE IT WILL TURN BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576485 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET 3GTQ-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other