HARMONY® P3, SERVICE TEST CASE

Description of Event or Problem

THIS EVENT OCCURRED OVERSEAS IN (B)(6) AND HAS BEEN TRANSLATED ACCORDINGLY PER OUR AFFILIATES IN EUROPE: A LOANER SYSTEM WAS PROVIDED TO THE CUSTOMER IN ORDER TO FIT THE PATIENT WITH SO THAT THE PATIENT WAS NOT IMMOBILIZED DURING HIS/HER REPAIRS. PER THE PROVIDED LOANER KIT, MULTIPLE FUNCTIONAL RINGS ARE PROVIDED IN ORDER TO ALLOW THE CUSTOMER TO CHOOSE THE MOST APPROPRIATE FITTING FOR THE PATIENT BASED ON STIFFNESS. THE CUSTOMER DID NOT FOLLOW THE PROVIDED INSTRUCTIONS AND IFU AND DID NOT APPROPRIATELY TIGHTEN THE FUNCTIONAL RING TO THE PUMP SYSTEM WHICH IS A REQUIREMENT AS SPECIFIED IN THE INSTRUCTIONS FOR USE. THE PATIENT WAS USING THE PRODUCT AND WHILE IN USE THE FUNCTIONAL RING BECAME DETACHED FROM THE PUMP SYSTEM AND THE PATIENT FELL TO THE GROUND. ACCORDING TO THE INITIAL REPORTER, THE FALL CAUSED THE PATIENT TO FRACTURE HIS/HER SHOULDER. FOLLOW-UP WITH REGARD TO THE HEALTH OF THE PATIENT HAS BEEN ONGOING. AT THIS POINT, MULTIPLE ATTEMPTS TO GAIN THE ADDITIONAL INFORMATION RELATED TO AGE, WEIGHT, HEIGHT, PATIENT SEX AND OVERALL EVENT DETAILS HAVE BEEN REQUESTED. ALL OF THIS INFORMATION HAS BEEN DOCUMENTED IN THE RECORD.