A USER REPORTED A FORWARD FALL OF THE DEVICE WHILE DESCENDING 3 OUTDOOR, CARPETED STEPS IN ASSISTED STAIR FUNCTION. USER REPORTED THAT HE HIT HIS HEAD ON THE FLOOR AND SUSTAINED A BROKEN NOSE AND INJURY THAT REQUIRED SUTURES. USER REPORTED THAT HE WAS WEARING THE PROVIDED LAP BELT AT THE TIME OF THE EVENT. INITIAL EVALUATION BY SERVICE HOTLINE PERSONNEL INDICATED A FORWARD FALL OF THE DEVICE, AS A RESULT OF A POSSIBLE CLUSTER SAFETY LOCK CONDITION WHILE DESCENDING STAIRS. USER WAS ADVISED THAT BASED ON THE REPORTED CIRCUMSTANCES, A FIELD SERVICE VISIT WOULD BE REQUIRED TO INSPECT THE DEVICE AND RETRIEVE THE ELECTRONIC CONFIGURATION FILE (ECF) FOR EVALUATION. USER STATED THAT HE WOULD CALL BACK TO SCHEDULE SERVICE FOLLOWING RECEIPT OF MEDICAL ATTENTION. (B)(4).
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Patient 1
SERVICE WAS DISPATCHED TO INSPECT THE DEVICE AND RETRIEVE THE ECF FOR EVALUATION. 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. ECF REVIEW DETERMINED THAT THE DEVICE ENTERED STAIR FUNCTION AND A FRAME LEAN STOP WAS RECORDED. EIGHTEEN SECONDS LATER, THE DEVICE RECORDED AN ALERT INDICATING CLUSTER SAFETY LOCK (GOING DOWN). WITHIN 1 SECOND, THE DEVICE WENT TO A CONTROLLER FAILURE CONDITION DUE TO ITS PITCH LIMIT BEING EXCEEDED. NO FURTHER ALARMS WERE PRESENT IN THE LOGS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE BLACK BOX DATA FOR THIS EVENT WAS NOT AVAILABLE. ANALYSIS DETERMINED THAT THE DEVICE DID NOT MALFUNCTION, AND BEHAVED AS EXPECTED FOR THE GIVEN INPUTS. THE DEVICE ENTERED CLUSTER SAFETY LOCK, AND WENT TO CONTROLLER FAILURE, DUE TO EXCEEDING ITS PITCH LIMIT. CLUSTER SAFETY LOCK IS THE DEVICE'S DETECTION OF A LOSS OF CONTROL DURING STAIR CLIMBING. NO DEVICE MALFUNCTION IS INDICATED. FURTHER REVIEW OF THE USER'S EVENT HISTORY INDICATED (3) EVENTS WITHIN 4 HOURS ON THE SAME DATE. THE USER WAS CONTACTED BY COMPANY PERSONNEL AND OFFERED ADDITIONAL STAIR CLIMBING TRAINING, WHICH WAS ACCEPTED, AND HAS BEEN SCHEDULED FOR (B)(6) 2009. THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY.