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).
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Patient 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.