TCM

Additional Manufacturer Narrative

THERE IS NO INDICATION THAT THE DEVICE HAS FAILED. ACCORDING TO THE OPERATOR'S MANUAL, THE SITE FOR THE ELECTRODES MUST BE CHANGED AT LEAST EVERY FOURTH HOUR. SITE TIME ALARM FOR CHANGE OF ELECTRODE SITE HAS BEEN GIVEN AFTER 4 HOURS, BUT THE CUSTOMER HAS IGNORED THE ALARMS. THEY HAVE LEFT THE ELECTRODES IN THE SITE FOR AN EXTRA 30 MINUTES AFTER THE ALARM HAD BEEN ISSUED. THIS HAS BEEN DONE IN SPITE OF THE FOLLOWING WARNINGS IN THE OPERATOR'S MANUAL: DO NOT ALLOW THE TCPO2/TCPCO2 ELECTRODE TEMPERATURE TO EXCEED 43 DEGREE C FOR NEONATES AND 44 DEGREE C FOR ADULTS IF ELECTRODES ARE ATTACHED TO SKIN FOR MORE THAN FOUR HOURS. TCPO2/TCPCO2 ELECTRODE AND REUSABLE SPO2 SENSORS MUST BE MOVED TO A NEW SITE AT LEAST EVERY FOUR HOURS. BECAUSE INDIVIDUAL SKIN CONDITION AFFECTS THE ABILITY OF THE SKIN TO TOLERATE ELECTRODE/SENSOR PLACEMENT, IT MAY BE NECESSARY TO CHANGE THE ELECTRODE/SENSOR SITE MORE FREQUENTLY WITH SOME PTS. IF SKIN INTEGRITY CHANGES, MOVE THE ELECTRODE/SENSOR TO ANOTHER SITE. WE HAVE TRIED TO OBTAIN MORE SPECIFIC INFO ABOUT THE BURN FROM THE CUSTOMER, UNTIL NOW TO NO AVAIL. FROM THE AVAILABLE INFO, IT IS STILL NOT CLEAR WHETHER THE DEGREE OF THE BURN CONSTITUTES A SECOND DEGREE BURN, BUT WE HAVE TO CONSIDER THIS A POSSIBILITY. OUR DISTRIBUTOR HAS VISITED THE CUSTOMER AND RE-TRAINING HAS BEEN PLANNED.

Description of Event or Problem

THE CUSTOMER CLAIMED THAT THREE BABIES HAD BEEN BURNED BY THE TRANSCUTANEOUS ELECTRODES USED WHEN MEASURING PCO2 VALUES (ALLEGEDLY A RED RING THAT DID NOT DISAPPEAR AND POSSIBLE SOME PEELING OF SKIN).