BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M51P BLUE BASE W/MK5 NX SPJ+ 9153642087

    MDR report key: 5028030 · Received August 25, 2015

    Report

    Report Number
    1525712-2015-04378
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    July 31, 2015
    Report Date
    September 30, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: CONSUMER POWER WHEELCHAIRS, OTHER, OTHER/DEFECTIVE. CHAIR WAS RETURNED WITH DEAD BATTERIES/ALSO JOYSTICK CABLE NOT CONNECTING CORRECTLY/CHAIR WAS FUNCTIONAL AFTER REPLACING BATTERIES AND JOYSTICK/ONLY FOUND TWO ERROR CODES INDICATING POSSIBLE ISSUE WITH JOYSTICK OR OTHER ELECTRONIC COMPONENT. COMPLAINT OF JERKING LEFT TO RIGHT, TURNING IN CIRCLES, WON¿T GO AT SLOW SPEED 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: CONSUMER POWER WHEELCHAIRS, OTHER, OTHER/DEFECTIVE. CHAIR WAS RETURNED WITH DEAD BATTERIES/ALSO JOYSTICK CABLE NOT CONNECTING CORRECTLY/CHAIR WAS FUNCTIONAL AFTER REPLACING BATTERIES AND JOYSTICK/ONLY FOUND TWO ERROR CODES INDICATING POSSIBLE ISSUE WITH JOYSTICK OR OTHER ELECTRONIC COMPONENT. ENDUSER CALLED DEALER STATING THAT HIS PWC WAS JERKING LEFT TO RIGHT, TURNING IN CIRCLES, WON'T GO AT SLOW SPEED, ETC.

    Description of Event or Problem · 1

    ENDUSER CALLED DEALER STATING THAT HIS PWC WAS JERKING LEFT TO RIGHT, TURNING IN CIRCLES, WON'T GO AT SLOW SPEED, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559691 M51P BLUE BASE W/MK5 NX SPJ+ 9153642087 WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET M51P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other