BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 7095552 · Received December 7, 2017

    Report

    Report Number
    9615350-2017-00007
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    UDI-DI
    00754014710065
    PMA / PMN Number
    K150574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2017, "BOLT THAT HOLDS ARM BROKE" WAS REPORTED TO MOTION CONCEPTS BY THE DEALER ((B)(4)). ON (B)(4) 2017, UPON REQUEST BY THE DEALER, MOTION CONCEPTS SENT OUT A REPLACEMENT PARTS ORDER CONSISTING OF A TRC2536 CANTILEVER ARMREST. ASSEMBLY INSTRUCTIONS WERE PROVIDED BY MOTION CONCEPTS WITH THE PARTS ORDERS TO COMPLETE THE INSTALLATION OF THE REPLACEMENT PARTS. FROM THE END USER REPORT (EMAIL ON (B)(4) 2017), IT APPEARS THAT ONLY A PORTION OF THE CANTILEVER ARMREST ASSEMBLY WAS REPLACED BY THE DEALER, NOT THE COMPLETE REPLACEMENT ASSEMBLY THAT WAS SHIPPED BY MOTION CONCEPTS TO THE DEALER ON (B)(4) 2017. ON (B)(4) 2017, THE DEALER WAS ADVISED THAT MOTION CONCEPTS WILL BE SENDING ANOTHER REPLACEMENT PARTS ORDER AND THE COMPLETE ARMREST ASSEMBLY MUST BE INSTALLED AS PER THE INSTRUCTIONS PROVIDED WITH THE ORDER.

    Description of Event or Problem · 1

    ON 09-NOV-2017, MOTION CONCEPTS WAS NOTIFIED BY (B)(4) (MOTION CONCEPTS IMPORTER) THAT ONE OF THEIR DEALER (B)(4) REPORTED THE FOLLOWING INCIDENT: "THE RIGHT CHAIR ARM FELL AGAIN ON CONSTANCE. THIS TIME IT LEFT A 2.5X.5 ABRASION AND BRUISE. THE ARM WAS REPLACED AS WELL AS THE M8 HEX HEAD BOLT. HOWEVER, THE LEAF SPRING WHICH HOLDS THE ARM IN UPWARD POSITION WAS NOT. WHEN THE BOLT SHEARED THE FIRST TIME, IT BENT AND FATIGUED THE SPRING, "SO THAT NO IT MAKES NO CONTACT WITH THE HEX HEAD BOLT." IT IS BENT AWAY FROM THE ARM. THE LEFT ARM IS INTACT AND WORKS. IN THAT CASE, THE BOLT HEAD LOCKS UNDER THE SPRING IN THE UPRIGHT POSITION PREVENTING THIS TYPE OF INJURY. THIS NEEDS IMMEDIATE REMEDIATION. ALSO, THERE REMAINS A CLIP SPRING MISSING ON THE BACK-CONTROL WIRE COVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877539 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP 45T-12L-RESR-MAXX 00754014710065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other