BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 6980860 · Received October 26, 2017

    Report

    Report Number
    9615350-2017-00005
    Event Type
    Injury
    Date Received
    October 26, 2017
    Report Date
    October 26, 2017
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    PMA / PMN Number
    K021264
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 26-MAR-2007, THE IDENTIFIED MOTION CONCEPTS SEATING SYSTEM (SERIAL NUMBER (B)(4)) WAS SHIPPED TO THE DEALER, (B)(4). PREVIOUS TO THIS ALLEGED INCIDENT, THERE HAVE BEEN NO MALFUNCTIONS REPORTED TO MOTION CONCEPTS ON THIS SEATING SYSTEM. ON 27-JUL-2017, UPON REQUEST BY THE DEALER ((B)(4)), MOTION CONCEPTS SENT OUT A REPLACEMENT PARTS ORDER CONSISTING OF A RECLINE ACTUATOR ((B)(4)) ALONG WITH THE FOLLOWING ADDITIONAL COMPONENTS: EXTRUDED RECLINE BACK POST ((B)(4)) AND ESR PAN LINK ((B)(4)). INSTALLATION AND ASSEMBLY INSTRUCTIONS WERE PROVIDED BY MOTION CONCEPTS WITH THE PARTS ORDERS IN ORDER TO COMPLETE THE INSTALLATION OF THE REPLACEMENT PARTS. AT THIS TIME, MOTION CONCEPTS IS NOT ABLE TO CONFIRM WHETHER THE PROPER INSTALLATION INSTRUCTIONS WERE FOLLOWED BY THE DEALER ((B)(4)), OR IF THE INSTALLATION OF THE REPLACEMENT PARTS WAS ACTUALLY COMPLETED BY THE DEALER ((B)(4)), PRIOR TO THE ALLEGED INCIDENT. TO DATE, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO MOTION CONCEPTS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, MOTION CONCEPTS WAS NOTIFIED BY (B)(6) (MOTION CONCEPTS IMPORTER) THAT ONE OF THEIR DEALERS ((B)(4)) REPORTED THE FOLLOWING INCIDENT: PER (B)(4) (TERRITORY BUSINESS MANAGER) WAS NOTIFIED BY ONE OF THEIR DEALER (B)(4) ADVISED END-USER STATED ACTUATOR FOR RECLINE BROKE CAUSING HIM TO FALL OUT THE CHAIR AND REINJURE TO HIS SPINE. (B)(4) ADVISED NOT AWARE IF END-USER SOUGHT MEDICAL ATTENTION. (B)(4) ADVISED DEALER STATED END-USER ADVISED HE HAS HIRED AN ATTORNEY. (B)(4) ADVISED NOT AWARE IF END-USER IS CURRENTLY STILL USING THE CHAIR. (B)(4) AND DEALER STATED END-USER HAS BEEN DELAYING ON GETTING A NEW CHAIR. (B)(4) ADVISED DEALER PROVIDED A NUMBER OF (B)(4) THAT HAS TO DO WITH HIS CHAIR. (B)(4) ADVISED DEALER ALSO PROVIDED A DATE OF (B)(4) 2007 WHICH IS WHEN CHAIR WAS PROVIDED TO END-USER. (B)(4) PROVIDED THE BASE OF THE CHAIR AND IT WAS SHIPPED TO MOTION CONCEPTS FOR THE SEATING. (B)(4) COULD NOT PROVIDE PATIENT WEIGHT OR ANY FURTHER INFORMATION. SERIAL NUMBER ONLY COMES UP IN THEIR ORACLE SYSTEM. NO RETURN DONE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760489 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP TRX-ULTRESR(CG)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other