3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM

Description of Event or Problem

USER FACILITY REPORTED IN THE OPERATING ROOM THE 3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM POWER ADAPTER CABLE "POSSIBLY" INTERFERED WITH THE ENTROPY METER. THE CABLE FROM THE ENTROPY METER AND 3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM POWER CABLES WERE NEXT TO THE PATIENT AT THE TIME OF THE INCIDENT. THE ENTROPY READING ON THE MONITOR WAS OVER 90, DESPITE INCREASING AND DECREASING ANESTHETIC AGENTS. THE ANESTHESIOLOGIST MOVED THE 3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM AWAY FROM THE ENTROPY CABLE AND THE ENTROPY VALUE DROPPED TO 25. THE 3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM POWER SUPPLY WAS VISUALLY INTACT FROM THE EXTERIOR. THERE WERE NO SIGNS OF DAMAGE ON THE DEVICE HOUSING, NO SCRATCHES, AND THE DC CONNECTOR WAS INTACT AND STRAIGHT.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS ACCORDING TO THE CUSTOMER DUE TO THE LOCAL CARRIER BEING UNABLE TO RETURN THE DEVICE; 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.