BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDEPENDENCE IBOT 4000 MOBILITY SYSTEM

    MDR report key: 1618155 · Received February 23, 2010

    Report

    Report Number
    3003508375-2010-00001
    Event Type
    Injury
    Date Received
    February 23, 2010
    Date of Event
    January 21, 2010
    Report Date
    February 18, 2010
    Manufacturer
    INDEPENDENCE TECHNOLOGY, L.L.C.
    Product Code
    IMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO INSPECT THE DEVICE FOR DAMAGE AND TO RETRIEVE THE ELECTRONIC CONFIGURATION FILE (ECF) FOR REVIEW/ANALYSIS. A REPORT ON FIELD SERVICE ACTIVITY (SAR) AND A DEVICE CHECKOUT RECORD (FCR) WAS FORWARDED TO THE COMPLAINT HANDLING UNIT (CHU) PER STANDARD OPERATING PROCEDURE. THE SERVICE ENGINEER NOTED DAMAGE TO BOTH UPPER LEG REST SUPPORT SIDE WELDS, FRONT LIGHT ASSEMBLY AND TWO BULBS AS A RESULT OF THE EVENT. DAMAGED PARTS WERE SUBSEQUENTLY REPLACED AND THE DEVICE RETURNED TO SERVICE. THE RETRIEVED ECF WAS REVIEWED BY ENGINEERING PERSONNEL. THE DEVICE LOGS DO NOT SHOW ANY INDICATION OF A DEVICE MALFUNCTION OR FAULT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE PRODUCT DHR WAS ALSO CONDUCTED AND SHOWED NO INDICATION OF ANY MFG ISSUE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT IS CONCLUDED THAT THIS IS AN ADVERSE EVENT AND NOT A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    USER REPORTED THAT ON (B) (6) 2009, HE WAS CROSSING THE STREET IN STANDARD FUNCTION WHEN HE WAS HIT ON THE RIGHT SIDE BY A VEHICLE GOING APPROX 30-35 MPH. USER STATES THAT THE DEVICE DID NOT TIP OVER FROM THE IMPACT, BUT JUST SPUN IN CIRCLES. USER REPORTED THAT HE SUSTAINED A BROKEN RIGHT FEMUR AS A RESULT OF THE IMPACT, REQUIRING SURGERY TO IMPLANT A METAL ROD. USER ALSO STATES THE POLICE AND AMBULANCE PERSONNEL WERE UNABLE TO TRANSPORT THE DEVICE SO HE (USER) WENT HOME TO GET HIS MANUAL WHEEL CHAIR AND HAVE HIS SON THEN DRIVE HIM TO THE HOSPITAL. USER REPORTED THAT HE FELL WHILE TRANSFERRING INTO HIS MANUAL WHEEL CHAIR FROM THE IBOT. AT THAT TIME, HIS SON DECIDED TO HAVE AN AMBULANCE TRANSPORT THE USER TO HOSPITAL. THE DEVICE REPORTEDLY SUSTAINED DAMAGE FROM THE IMPACT AND SERVICE WAS DISPATCHED TO INSPECT THE DEVICE AND RETRIEVE THE ECF FOR REVIEW. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDEPENDENCE IBOT 4000 MOBILITY SYSTEM STAIR CLIMBING WHEELCHAIR IMK INDEPENDENCE TECHNOLOGY, L.L.C. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization