SMART CABLE NMT MODULE AND ACCESSORIES

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE NIHON KOHDEN (NK) EMPLOYEE REPORTED THAT THE PHYSICIAN WAS SUPERVISING A NEW CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) WHO RE-DOSED A PATIENT WITH A PARALYTIC BASED ON A TRAIN OF FOUR (TOF) RATIO READING OF 94% WHEN USING THIS NMT SMART POD, TOF DEVICE. NO PATIENT HARM WAS REPORTED. THE PHYSICIAN HAS REQUESTED LITERATURE AND GUIDANCE ON EVALUATING EMG WAVEFORMS FOR TROUBLESHOOTING IN CASES WHERE THE TOF RATIO DOES NOT ALIGN WITH THE CLINICAL PRESENTATION (E.G., DISTINGUISHING BETWEEN NOISE AND PLACEMENT ISSUES). THE PHYSICIAN AIMS TO BUILD CONFIDENCE IN TEACHING OTHER PROVIDERS HOW TO INTERPRET AND TROUBLESHOOT EMG WAVEFORM DATA EFFECTIVELY. INVESTIGATION SUMMARY: MULTIPLE ATTEMPTS WERE MADE TO COLLECT ADDITIONAL INFORMATION REGARDING THE COMPLAINT. HOWEVER, THERE HAS BEEN NO RESPONSE FROM THE CUSTOMER. THERE IS NOT ENOUGH INFORMATION TO PERFORM AN INVESTIGATION. TECHNICAL INFORMATION RELEVANT TO THE CUSTOMER'S REQUEST CAN BE FOUND IN THE OPERATOR'S MANUAL FOR THE AF-201P NMT MODULE AND/OR THE OPERATOR'S MANUAL FOR THE CONNECTED BEDSIDE MONITOR OR INPUT UNIT. ADDITIONALLY, IMPROVED QUALITY AND FUNCTIONALITY FOR AF-201PA DEVICES IS PLANNED IN SOFTWARE VERSION 05-00. PLANNED FEATURES THAT COULD ASSIST CLINICIANS IN NAVIGATING SCENARIOS SUCH AS THE ONE DESCRIBED IN THE COMPLAINT INCLUDE IMPROVED NOISE CORRECTION FUNCTION AND IMPROVED ACCURACY OF THE TOF RATIO FORMULA. A SIGNIFICANT TREND HAS NOT BEEN OBSERVED THAT WOULD WARRANT ANY FURTHER CORRECTIVE ACTION. NIHON KOHDEN WILL CONTINUE TO TREND AND MONITOR.

Description of Event or Problem

THE NIHON KOHDEN EMPLOYEE REPORTED THAT THE PHYSICIAN WAS SUPERVISING A NEW CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) WHO RE-DOSED A PATIENT WITH A PARALYTIC BASED ON A TRAIN OF FOUR (TOF) RATIO READING OF 94% WHEN USING THIS NMT SMART POD, TOF DEVICE. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE NIHON KOHDEN EMPLOYEE REPORTED THAT THE PHYSICIAN WAS SUPERVISING A NEW CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) WHO RE-DOSED A PATIENT WITH A PARALYTIC BASED ON A TRAIN OF FOUR (TOF) RATIO READING OF 94% WHEN USING THIS NMT SMART POD, TOF DEVICE. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE NIHON KOHDEN (NK) EMPLOYEE REPORTED THAT THE PHYSICIAN WAS SUPERVISING A NEW CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) WHO RE-DOSED A PATIENT WITH A PARALYTIC BASED ON A TRAIN OF FOUR (TOF) RATIO READING OF 94% WHEN USING THIS NMT SMART POD, TOF DEVICE. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE CO2 SENSOR KIT: BEDSIDE MONITOR (BSM): MODEL #: NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI RETURNED TO NIHON KOHDEN: NA.