MULTI-LINK¿ ADAPTER

Additional Manufacturer Narrative

AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. THE CUSTOMER MENTIONED THAT THEY TRIED SEVERAL BOXES AND HAD THE SAME ISSUE - UNSURE THAT IT IS NOT A BOX ISSUE BUT MAYBE A LARGER MONITORING ISSUE.WHEN THIS PDM WAS CONNECTED TO A MONITOR FOR TESTING IN THE SHOP, IT ALARMED ""CUFF LOOSE"" AS PATIENT WAS NOT DISCHARGED BEFORE IT WAS REMOVED FROM THE MONITOR ON THE UNIT. THE CUSTOMER PERFORMED NIBP MEASUREMENT USING CALIBRATED TEST EQUIPMENT AND COULD NOT REPRODUCE THE REPORTED PROBLEM. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED YET.

Description of Event or Problem

IT WAS REPORTED TO (B)(4) MEDICAL THAT THE TELEMETRY BOX DOES NOT READ PROPERLY ON PATIENTS. THE TELEMETRY BOX WILL NOT PICKUP OR READ ASYSTOLE ON A PATIENT WHO HAS A CARDIAC RHYTHM. THE STAFF STATED THAT THEY SWITCHED OUT THIS DEVICE WITH ANOTHER AND ISSUE DID NOT RE OCCUR. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT. THE STAFF STATED THAT THEY SWITCHED OUT THIS DEVICE WITH ANOTHER AND ISSUE DID NOT REOCCUR. WHEN THIS PDM WAS CONNECTED TO A MONITOR FOR TESTING IN THE SHOP, IT ALARMED "CUFF LOOSE" AS PATIENT WAS NOT DISCHARGED BEFORE IT WAS REMOVED FROM THE MONITOR ON THE UNIT. THE CUSTOMER PERFORMED NIBP MEASUREMENT USING CALIBRATED TEST EQUIPMENT AND COULD NOT REPRODUCE THE CUSTOMER REPORTED PROBLEM.