BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX

    MDR report key: 5590231 · Received April 20, 2016

    Report

    Report Number
    1525712-2016-01077
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Report Date
    May 11, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION CHANGED. PRODUCT WAS RETURNED FOR EVALUATION. THE RETURN FIELDS IN ORACLE STATE: CUSTOM POWER WHEELCHAIRS. CABLE RETURNED MISSING ONE END OF ANDERSON CONNECTORS AND THE SHRINK TUBING IS CUT. PRODUCT RECEIVED EXPANDED EVALUATION. THE EXPANDED EVALUATION REPORT STATES: VISUAL INSPECTION- IT WAS OBSERVED THAT THE PTC LNX ADAPTER WAS ADULTERATED. WHERE THE MINI-FIT JR MOLEX HOUSING WAS LOCATED, THERE WERE TWO AFTERMARKET RING TERMINALS CONNECTED TO THE WHITE AND BLACK WIRES. CONCLUSIONS- UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS NOT CONFIRMED FOR THE PTC LNX ADAPTER OF PRODUCING SMOKE, SPARKS, ARCING, OR FIRE DURING FUNCTIONAL TESTING. ALSO, IT WAS OBSERVED THAT THERE WAS NO EVIDENCE OF SMOKE, SPARKS, ARCING, FIRE, OR MELTING ON ANY OF THE RETURNED COMPONENTS OF THE PTC LNX ADAPTER. COMPLAINT WAS NOT 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

    THE DEALER STATED THAT THE ACTUATOR WILL NOT OPERATE THE LEGREST. DURING TROUBLESHOOTING THE DEALER DETERMINED THAT THE JUMPER THAT COMES DIRECTLY OUT OF THE CONTROLLER TO THE ACTUATOR APPEARS TO LOOK AS IF IT HAS MELTED.

    Description of Event or Problem · 1

    THE DEALER STATED THAT THE ACTUATOR WILL NOT OPERATE THE LEGREST. DURING TROUBLESHOOTING THE DEALER DETERMINED THAT THE JUMPER THAT COMES DIRECTLY OUT OF THE CONTROLLER TO THE ACTUATOR APPEARS TO LOOK AS IF IT HAS MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247178 TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1