3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR ANALYSIS. LEAKAGE CURRENT MEASURED FROM THE POWER SUPPLY WAS IN COMPLIANCE WITH THE IEC STANDARD. A DEVICE MALFUNCTION WAS NOT CONFIRMED. ADDITIONALLY, IT WAS REPORTED THE OTHER DEVICE IN USE WAS A CARESCAPE/ENTROPY MONITOR. THE CARESCAPE/ENTROPY DEVICE OPERATOR¿S MANUAL INFORMS THE USER THAT A HIGH-QUALITY EEG SIGNAL IS THE PREREQUISITE FOR A SUCCESSFUL ENTROPY CALCULATION; ADDITIONALLY, IT CAUTIONS THE USER THAT EEG MEASUREMENT IS INHERENTLY VERY SENSITIVE AND IS PRONE TO ARTIFACTS SUCH AS EXTERNAL ELECTRICAL INTERFERENCE. FURTHER, THE CARESCAPE/ENTROPY DEVICE OPERATOR¿S MANUAL CAUTIONS THE USER THAT THE DEVICE SHOULD NOT BE USED ADJACENT TO, OR STACKED WITH, OTHER EQUIPMENT AND TO CONSULT QUALIFIED PERSONNEL REGARDING DEVICE/SYSTEM CONFIGURATION. IN THE BAIR HUGGER TEMPERATURE MONITORING SYSTEM OPERATORS' MANUAL, THE USER IS WARNED THAT CARE SHOULD BE USED WHEN OPERATING THE DEVICE ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. IF ADJACENT OR STACKED USE IS NECESSARY, THE BAIR HUGGER TEMPERATURE MONITORING SYSTEM AND THE OTHER EQUIPMENT SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED. IT IS UNKNOWN IF THESE INSTRUCTIONS, INCLUDED IN BOTH THE CARESCAPE/ENTROPY AND BAIR HUGGER TEMPERATURE MONITORING SYSTEM OPERATOR¿S MANUALS, WERE FOLLOWED BY THE USER. SOLVENTUM WILL CONTINUE TO MONITOR.

Description of Event or Problem

A USER FACILITY REPORTED A DISTURBANCE TO THE PATIENT'S ENTROPY VALUE WHILE USING 3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM. AFTER INDUCTION OF ANESTHESIA, THE ENTROPY VALUE SHOWED 70-90 EVEN THOUGH LARGE AMOUNTS OF ANESTHESIA AGENTS WERE GIVEN. THEY REMOVED THE SENSOR AND THE VALUE DROPPED BELOW 30. AN ANESTHESIOLOGIST WAS PRESENT IN THE ROOM AND NO OTHER SYMPTOMS WERE REPORTED. THE PATIENT RECEIVED AN UNNECESSARY NUMBER OF ANESTHETIC AGENTS. NO INJURIES OR MEDICAL INTERVENTIONS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS; THEREFORE, SOLVENTUM IS UNABLE TO DETERMINE ROOT CAUSE. IT IS UNKNOWN WHAT ANESTHESIA MONITOR WAS IN USE AND IF THE CUSTOMER WAS FOLLOWING THE ANESTHESIA MONITOR INSTRUCTIONS FOR USE. THE 3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM IS INTENDED FOR USE IN THE ELECTROMAGNETIC ENVIRONMENT IN WHICH RADIATED DISTURBANCES ARE CONTROLLED. THE INSTRUCTIONS FOR USE INCLUDE THE USER OF THE MONITORING SYSTEM CAN HELP PREVENT ELECTROMAGNETIC INTERFERENCE BY MAINTAINING A MINIMUM DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE TEMPERATURE MONITORING SYSTEM AS RECOMMENDED, ACCORDING TO THE MAXIMUM OUTPUT POWER OF THE COMMUNICATIONS EQUIPMENT. SOLVENTUM WILL CONTINUE TO MONITOR.