MON-A-THERM

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE PROBE ON A NEWBORN WITH SEVERE NEONATAL ANOXIC-ISCHEMIA AT 7:30AM, INCONSISTENT RECTAL TEMPERATURE READINGS WERE OBSERVED DURING HYPOTHERMIA THERAPY. THE MONITOR INDICATED THE PROBE TEMPERATURE OF 33.5°C, WHILE THE WATER TEMPERATURE WAS 40°C. THE WARMING TABLE WAS ON AND THE MATTRESS WAS AT 30°C. THE CHILD'S TEMPERATURE WAS RECHECKED AXILLARY AND FOUND TO BE 36.6°C. THE SAME INCIDENT OCCURRED AGAIN THE SAME DAY AT 9:00PM. THE RECTAL PROBE WAS SUBSEQUENTLY REPLACED AND RECONNECTED, AND THE WARMING TABLE WAS TURNED OFF. COOLING WAS TEMPORARILY PAUSED WHILE AWAITING THE PHYSICIAN'S DECISION, AFTER WHICH HYPOTHERMIA THERAPY WAS RESUMED WITHIN HOURS. UPON REVIEWING THE MACHINE¿S LOG FILE, A SUDDEN LOSS OF TEMPERATURE MONITORING WAS NOTED, INDICATING A BREAKAGE IN THE CONNECTION CABLE AND DISCONNECTION OF THE PROBE. THE CABLE¿S FUNCTIONALITY WAS VERIFIED; HOWEVER, THE PROBE WAS NOT RETAINED FOR FURTHER EVALUATION. THE DEATH OCCURRED FOLLOWING THE WITHDRAWAL OF ACTIVE THERAPIES BASED ON MEDICAL DECISION DUE TO THE VERY POOR NEUROLOGICAL PROGNOSIS OF THE PATIENT.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.