PRO 6000 W/SMALL CRADLE

Additional Manufacturer Narrative

THE THERMOSCAN PRO 6000 EAR THERMOMETER IS INDICATED FOR THE INTERMITTENT MEASUREMENT OF HUMAN BODY TEMPERATURE FOR PATIENTS HAVING AGES RANGING FROM NORMAL WEIGHT (FULL TERM) NEWBORN TO GERIATRIC ADULTS IN A PROFESSIONAL USE ENVIRONMENT. THE PROBE COVER IS USED AS A SANITARY BARRIER BETWEEN THE INFRARED THERMOMETER AND THE EAR CANAL. THE PRO 6000 TECHNOLOGY READS THE INFRARED ENERGY EMITTED BY THE TYMPANIC MEMBRANE AND SURROUNDING TISSUES TO DETERMINE THE PATIENT¿S TEMPERATURE. TO HELP ENSURE ACCURATE TEMPERATURE MEASUREMENTS, THE SENSOR ITSELF IS WARMED TO A TEMPERATURE CLOSE TO THAT OF THE HUMAN BODY. WHEN THE THERMOSCAN IS PLACED IN THE EAR, IT CONTINUOUSLY MONITORS THE INFRARED ENERGY UNTIL A TEMPERATURE EQUILIBRIUM HAS BEEN REACHED AND ACCURATE MEASUREMENT CAN BE TAKEN. THE DEVICE IFU STATES DO NOT DAMAGE PROBE LENS WINDOW. AVOID TOUCHING PROBE LENS WINDOW EXCEPT WHEN CLEANING. THE PROBE LENS WINDOW MUST BE KEPT CLEAN, DRY AND UNDAMAGED AT ALL TIMES TO ENSURE ACCURATE MEASUREMENTS. IF PROBE LENS WINDOW IS DAMAGED RETURN FOR SERVICE. THERE WAS NO REPORT OF INJURY WITH THE EVENT. HOWEVER, THE REPORTED MALFUNCTION COULD LEAD TO A SERIOUS INJURY IF THE EVENT WAS TO RECUR AND THE DEVICE WAS TO EXCEED A SAFE TEMPERATURE THRESHOLD. THEREFORE THIS EVENT IS CONSIDERED REPORTABLE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE PROBE TIP OF THEIR BRAUN PRO6000 OVERHEATED. THERE WERE NO ALLEGATIONS OF INJURY. THIS EVENT HAS BEEN CAPTURED IN HILL-ROM'S COMPLAINT HANDLING SYSTEM UNDER (B)(4).