SYNERGY SURFACE

Additional Manufacturer Narrative

NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING THE COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE AIR CELLS ON THE SYNERGY ELITE MATTRESS ARE SHIFTING TO ONE SIDE AND DO NOT SEEM TO FULLY INFLATE AND THE CUSTOMER HAS A NEW PRESSURE WOUND. CUSTOMER INDICATED PRIOR HISTORY OF FLAP SURGERY 3 1/2 YEARS AGO, DID NOT PROVIDE DETAILS OF LOCATION, AND ABOUT 6-8 MONTHS AGO PATIENT STARTED WITH A NEW PRESSURE SORE ON THE SACRUM AND IT IS STAGE 4. THE MEDICAL INTERVENTION PROVIDED FOR THE PRESSURE WOUND IS REGULAR DRESSING CHANGES AND THEY ARE GOING TO START USING A WOUND VAC AND THE HYPERBARIC CHAMBER. IT WAS ALSO REPORTED THE PATIENT WAS TRANSFERRED TO A REHAB FACILITY WHERE THE EXPECTED DURATION OF STAY WAS INITIALLY ESTIMATED AT 6¿8 MONTHS BUT WAS LATER REVISED TO APPROXIMATELY 20 DAYS. THE PATIENT STATED THAT THE MATTRESS WAS MANIPULATED BY A NON-BAXTER EMPLOYEE, DID NOT PROVIDE SPECIFIC DATE ON WHEN THIS OCCURRED. THE PERSON SEWED THE MATTRESS AIR CELLS AND AFTER 2-3 MONTHS THE CELLS COME LOOSE AND MATTRESS WOULD SEPARATE. INSTRUCTIONS IN THE IFU ARE OUTLINE USERS: ¿UNZIP THE TOP COVERLET FROM THE BOTTOM ENCASEMENT AND EXAMINE THE AIR CELLS AND AIR TUBES FOR LEAKS. IF A LEAK IS FOUND, CONTACT BAXTER TECHNICAL SUPPORT FOR ASSISTANCE.¿. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.