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Patient 1
ON (B)(6) 2019, SUNRISE MEDICAL CUSTOMER SERVICE CONTACTED (B)(6) TO GATHER ADDITIONAL INFORMATION REGARDING THIS INCIDENT. (B)(6) WAS ABLE TO SPEAK WITH THE END USER AND STATED THAT THE END USER ALLEGES THE INCIDENT OCCURRED TWO WEEKS PRIOR. HE SAYS HE WAS IN THE CHAIR TENDING TO HIS DAILY ACTIVITIES WHEN ALL OF THE SUDDEN THE WHEEL RIM POPPED AND 8 OR 9 SPOKES WENT FLYING OFF. HE CLAIMS THAT ONE OF THE SPOKES STRUCK HIM IN THE ARM, CAUSING AN INJURY THAT REQUIRED STITCHES. HE ALSO STATED THAT HE DID NOT KEEP THE WHEEL BECAUSE HE FELT IT WAS TOO DANGEROUS TO HAVE LAYING AROUND, SO HE THREW IT OUT. SUNRISE MEDICAL REGULATORY RESEARCHED THE HISTORY OF THE SUBJECT WHEELCHAIR AND FOUND NO RECORD OF THE CHAIR EVER BEING SERVICED SINCE ITS MANUFACTURE DATE OF 6/19/14. SUNRISE MEDICAL'S QUALITY ENGINEER REPORTED THAT THE SAME SPOKE WHEEL IS USED ON SEVERAL QUICKIE MANUAL WHEELCHAIRS AND THERE HAS NOT BEEN A FAILURE MODE OF THIS MAGNITUDE EVER BEING RECORDED IN THE PAST AND THAT IT IS HIGHLY UNLIKELY THAT THIS FAILURE OCCURRED DUE TO A MALFUNCTION OR DEFICIENCY IN THE PRODUCT. IT IS LIKELY, HOWEVER, THAT THE FAILURE OCCURRED DUE TO A LACK OF MAINTENANCE OR ABUSE OF THE CHAIR SINCE SO MANY SPOKES CAME LOOSE AT THE SAME TIME. IT IS STATED IN THE MAINTENANCE CHART, LOCATED ON PAGE 14 OF THE QUICKIE GT OWNER'S MANUAL TO CHECK THE WHEELS, TIRES AND SPOKES EVERY 3 MONTHS. IT ALSO STATES IN THE TROUBLESHOOTING CHART IN THE OWNER'S MANUAL: MAKE SURE ALL SPOKES AND NIPPLES ARE TIGHT ON RADIAL SPOKE WHEELS. SINCE THE END USER HAS THROWN AWAY THE WHEELS, SUNRISE MEDICAL IS UNABLE TO PERFORM A THOROUGH INSPECTION AND EVALUATION OF THE PRODUCT AND THEREFORE IS UNABLE TO VERIFY AND VALIDATE THE END USER'S CLAIM. HOWEVER, AS A COURTESY TO THE END USER AND AS A GOOD CUSTOMER SERVICE PRACTICE, SUNRISE MEDICAL HAS DECIDED TO ACCOMMODATE THE END USER WITH A REPLACEMENT WHEEL EVEN THOUGH HE HAS NOT PROVIDED ANY PROOF OF HIS CLAIM. NO FURTHER INVESTIGATION WILL BE PERFORMED BY SUNRISE MEDICAL AT THIS TIME.