3M¿ BAIR HUGGER¿ TEMPERATURE MONITORING SYSTEM

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.

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 DURING A PANCREATIC CANCER PROCEDURE. THE ENTROPY VALUE WAS SHOWING A HIGH READING AT TIMES AND WAS TREATED ACCORDINGLY. AT THE END OF THE PROCEDURE, THE THERMOMETER WAS REMOVED FROM THE PATIENT'S FOREHEAD AND THE ENTROPY VALUE DROPPED FROM APPROXIMATELY 70 TO 30. 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.