USER'S MOTHER REPORTED THAT USER SUSTAINED A MILD CONCUSSION, SCRATCHES ON BOTH ARMS THAT REQUIRED BANDAGING, AND A CONCUSSION ABOVE HIS RIGHT EYE, NOT REQUIRING SUTURES, FOLLOWING A SIDEWAYS FALL FROM THE DEVICE IN STANDARD FUNCTION. CALLER REPORTS THAT THE DEVICE DID NOT CONTACT ANY SURFACE OR FALL OVER. CALLER STATES THAT THE USER WAS ON A CONCRETE DECK OUTSIDE. HE LEANED OVER THE RIGHT ARMREST, WHEN THE BOLT HOLDING THE ARMREST BROKE OFF AND THE USER FELL ONTO THE CONCRETE DECK. USER'S FATHER IS A PHYSICIAN AND STATED THAT HIS SON HAD A CONCUSSION. CALLER STATES THAT THE USER WAS NOT WEARING THE PROVIDED LAP BELT AT THE TIME OF THE EVENT AS ADVISED IN ACCOMPANYING DEVICE LABELING. CALLER STATES THAT THERE WAS NO SERVICE CODE OR SERVICE WRENCH POSTING ON THE DEVICE. CALLER INQUIRED ABOUT THE ARMREST FASTENER SPECIFICATIONS, WHICH WERE PROVIDED. CALLER STATES THAT USER WILL REPAIR HIS DEVICE. THE CALLER WAS ADVISED THAT THERE SHOULD BE 2 BOLTS SECURING THE ARMREST TO THE DEVICE. (B)(4).
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Patient 1
SERVICE WAS DISPATCHED TO INSPECT THE DEVICE AND RETRIEVE THE ELECTRONIC CONFIGURATION FILE (ECP) FOR REVIEW. THE CUSTOMER ENGINEER (CE) CALLED WHILE ON SITE STATING THAT THE RIGHT ARMREST WAS DAMAGED AND NEEDED TO BE REPLACED. CE STATES THAT ONE OF THE SCREWS THAT CONNECTED THE ARMREST TO THE BACKREST HAD SHEARED OFF AND THE BRACKET WAS BENT. THE CE ALSO STATES THAT THE RIGHT FRONT LIGHT ASSEMBLY NEEDED TO BE REPLACED. CE ADVISED THE USER THAT THESE PARTS NEED TO BE REPLACED AND THE USER STATED THAT HE WILL CONTACT THE COMPANY WHEN READY TO PURCHASE. CE STATED THAT HE BELIEVED THAT THE DEVICE FELL OVER. CE ALSO REPORTED THAT THE BATTERIES WERE NO CHARGED AND WAS UNABLE TO RETRIEVE THE ECF. THE FCR INDICATED THAT THE DEVICE DOES NOT PASS FUNCTIONALITY CHECKS AND CANNOT BE RETURNED TO SERVICE. A FIELD SERVICE ACTIVITY / DEVICE CHECKOUT REPORT (ESAR) WAS FORWARDED TO THE COMPLAINT HANDLING UNIT (CHU) PER STANDARD OPERATING PROCEDURES. FURTHER ATTEMPTS ARE BEING MADE TO RETRIEVE THE ECF FOR REVIEW. HOWEVER, BASED ON THE NATURE OF THE EVENT, AND AS THE DEVICE WAS IN STANDARD FUNCTION, THE ECF IS NOT EXPECTED TO CONTAIN ANY PERTINENT INFO. THIS REPORT IS BEING FILED IN ADVANCE OF ECF RETRIEVAL AND REVIEW, WHICH, AS OF (B)(6) 2013, HAS BEEN UNSUCCESSFUL DUE TO THE USER NOT RETURNING TELEPHONE CALLS / MESSAGES REQUESTING ACCESS TO THE DEVICE. HOWEVER, IF ECF RETRIEVAL IS SUCCESSFUL AND CONTAINS ANY DATA RELEVANT TO THIS EVENT, A F/U REPORT WILL BE SUBMITTED.