BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPORT 20 IN X 16 IN 9153637574

    MDR report key: 5387824 · Received January 25, 2016

    Report

    Report Number
    1525712-2016-00247
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Report Date
    January 22, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL/UPDATED INFORMATION WAS ADDED TO REFLECT THE WHEEL ASSEMBLY BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. PER THE INITIAL EVALUATION, THE WHEEL WAS MISSING PARTS 1162864 (GEAR RING), 1166098 (SPACER), 1167101 (WHEEL HUB ADAPTER) AND 2 OF THE 4 SCREWS 1164040. AN EXPANDED EVALUATION WAS PERFORMED. THE EXPANDED EVALUATION CONFIRMED THAT ALL FOUR NUTS, THE RETAINING RING, GEAR RING, ALL FOUR SPACERS, AND THE HUB WHEEL ADAPTER WERE NOT RETURNED WITH THE WHEEL ASSEMBLY. THE BEARINGS WERE ABLE TO ROTATE, BUT THERE WAS A SCRATCH PRESENT ON ONE SIDE AND TWO OF THE FOUR SCREWS WERE MISSING. THE COMPLAINT OF THE UNIT HAVING A "SHREDDED" BEARING WAS NOT CONFIRMED. ADDITIONALLY, THE COMPLAINT OF THE WHEEL FALLING OFF OF THE CHAIR COULD NOT BE CONFIRMED, AS ONLY THE WHEEL WAS RETURNED FOR EVALUATION WITHOUT ITS PARENT CHAIR. THE UNDERLYING CAUSE OF THE COMPLAINT ISSUES COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PER THE DEALER, THE DRIVE WHEEL HAS FALLEN OFF AND THE BEARINGS ARE SHREDDED.

    Description of Event or Problem · 1

    PER THE DEALER THE DRIVE WHEEL HAS FALLEN OFF AND THE BEARINGS ARE SHREDDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48174 TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1