GENERAL PURPOSE PROBE, 400 SERIES 9 FR (+/-0.2)

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "TEMPERATURE PROBE IS NOT SHOWING THE RIGHT TEMPERATURE AND VERY SENSITIVE WHEN MOVING THE PROBE." THE SAMPLE WAS REQUESTED FROM VYAIRE, BUT IT COULD NOT BE RETURNED. BECAUSE NO SAMPLE COULD BE RETURNED, FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THE DEFECTIVE SAMPLE. DEROYAL INDUSTRIES REVIEWED 200 WORK ORDERS, THE FAILURE MODES AND EFFECTS ANALYSIS (FMEA), AND THE DEVICE HISTORY RECORD AND NO ISSUES WERE FOUND. AN INVENTORY CHECK WAS PERFORMED ON 125 PROBES AND ALL WERE FOUND TO BE ACCEPTABLE. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4) %. ROOT CAUSE: BECAUSE A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED ON THE DEFECTIVE SAMPLE AND NO ISSUES WERE IDENTIFIED IN DOCUMENTATION ON HAND, NO ROOT CAUSE CAN BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTION: BECAUSE NO ROOT CAUSE COULD BE DETERMINED, DEROYAL HAS NOT TAKEN ANY CORRECTIVE OR PREVENTIVE ACTIONS. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS SURROUNDING 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 MORE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A USER FACILITY REPORTED "THE TEMPERATURE PROBE IS NOT SHOWING THE RIGHT TEMPERATURE AND IS VERY SENSITIVE WHEN MOVING THE PROBE."