NASOPHARYNGEAL TEMPERATURE PRO, 9 FR, 18" TUBE / TWISTED CORD

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "ARCTIC SUN COMMUNICATING "PT MEASUREMENT ERRATIC. THERAPY STOPPED." AFTER ESOPHAGEAL TEMPS READ A LARGE RANGE OF VALUES IN A SHORT PERIOD OF TIME, CAUSING THE WATER TEMP TO BE 19-36 DEGREES IN A SHORT PERIOD OF TIME. VENDOR SUPPORT CONTACTED AND SUGGESTED A SHORT IN THE PROBE AS THE CAUSE." THIS COMPLAINT WAS ALSO REPORTED TO THE FDA WITH MEDWATCH (B)(4). THE DEVICE WAS NOT ABLE FOR RETURN. DEROYAL INDUSTRIES REVIEWED THE DEVICE HISTORY RECORD WITH THE WORK ORDER, FAILURE MODE AND EFFECT ANALYSIS (FMEA), AND FUNCTION RESULTS REVIEWED WITHIN. NO ISSUES WERE FOUND WITH THE MANUFACTURING PROCESS. PREVIOUS MATERIAL REVIEW REPORTS AS WELL AS PRODUCT IN PROCESS WERE REVIEWED AND NO SIMILAR ISSUES WERE FOUND. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). ROOT CAUSE: BECAUSE NO SAMPLE WAS AVAILABLE FOR RETURN AND NO ISSUES WERE FOUND WITHIN THE MANUFACTURING REVIEW, THE ISSUE COULD NOT BE RECREATED AND THEREFORE NO ROOT CAUSE WAS ABLE TO BE ESTABLISHED. CORRECTIVE OR PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE WAS DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A USER FACILITY REPORTED, "ARCTIC SUN COMMUNICATING "PT MEASUREMENT ERRATIC. THERAPY STOPPED." AFTER ESOPHAGEAL TEMPS READ A LARGE RANGE OF VALUES IN A SHORT PERIOD OF TIME, CAUSING THE WATER TEMP TO BE 19-36 DEGREES IN A SHORT PERIOD OF TIME. VENDOR SUPPORT CONTACTED AND SUGGESTED A SHORT IN THE PROBE AS THE CAUSE".