TRUSAT

Additional Manufacturer Narrative

UDI NOT REQUIRED. LEGAL MANUFACTURER: (B)(4). THE CUSTOMER DID NOT PROVIDE A SERIAL NUMBER FOR THE DEVICE. THE INFORMATION IS NOT AVAILABLE BECAUSE THE CUSTOMER DID NOT PROVIDE A SERIAL NUMBER FOR THE DEVICE. GE HEALTHCARE'S INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT SUSTAINED A BURN INJURY FROM THE TRUSAT PULSE OXIMETER WHILE UNDERGOING A MRI SCAN. PER THE USER MANUAL, THE TRUSAT IS NOT INTENDED FOR USE IN A MRI ENVIRONMENT.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: GE HEALTHCARE (GEHC) WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION WITH REGARDS TO THE TRUSAT INVOLVED, ITS EVALUATION AND THE SPO2 ACCESSORY IN USE. IN ADDITION, THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER DETAILS PERTAINING TO THE PATIENT'S CURRENT STATUS. A PICTURE OF THE REPORTED INJURY WAS PROVIDED FOR GEHC EVALUATION. ALSO, A PICTURE OF THE SPO2 SENSOR THAT WAS IN USE WAS SUBSEQUENTLY OBTAINED. PER EVALUATION BY GEHC ENGINEERING, IT WAS DETERMINED THAT THE SPO2 SENSOR IN USE AT THE TIME WAS A GENERIC SENSOR, AND NOT MANUFACTURED BY GEHC. THE ACTUAL MANUFACTURER IS UNKNOWN. IN ADDITION TO THE WARNING THAT THE TRUSAT "IS NOT INTENDED FOR USE IN A MAGNETIC RESONANCE IMAGING (MR) ENVIRONMENT", THE TRUSAT USER'S GUIDE ALSO CONTAINS A WARNING TO USE "ONLY SENSORS AND CABLES SPECIFIED FOR USE WITH THIS MONITOR." GEHC HAS NOT IDENTIFIED ANY OTHER RECENT COMPLAINT ALLEGING A SIMILAR ISSUE IN RELATION TO THE TRUSAT. GEHC'S INVESTIGATION CONCLUDED THAT THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.