AF-201PA

Description of Event or Problem

NIHON KOHDEN CLINICAL APPLICATION SPECIALIST (NKCAS) WAS ON-SITE WHEN THE ISSUE OCCURRED THAT THE G9 MONITOR DID NOT ALARM FOR THE TOF ALARM (TRAIN OF FOUR) WHEN USING THIS NMT SMART POD, TOF DEVICE WITH A G9 BEDSIDE MONITOR (BSM) DURING A SURGICAL PROCEDURE. NK CAS CONFIRMED THE NMT SMART POD'S VALUE REACHED THE ALARM LEVEL LIMIT VALUE, BUT NO ALARM WAS TRIGGERED EVEN IN ALARM EVENTS. NO PATIENT HARM WAS REPORTED. NK CAS COPIED ALL CLINICAL SETTINGS FROM A KNOWN WORKING NMT SMART POD, TOF DEVICE BUT THE ISSUE PERSISTED. NK CAS CONCLUDED THAT IT WAS NOT THE G9 BEDSIDE MONITOR (BSM) THAT HAD THE ISSUE, IT WAS AN ISSUE WITH THE NMT SMART POD, TOF AND FURTHER INVESTIGATION IS ON-GOING BY NK.

Additional Manufacturer Narrative

NIHON KOHDEN CLINICAL APPLICATION SPECIALIST (NKCAS) WAS ON-SITE WHEN THE ISSUE OCCURRED THAT THE G9 MONITOR DID NOT ALARM FOR THE TOF ALARM (TRAIN OF FOUR) WHEN USING THIS NMT SMART POD, TOF DEVICE WITH A G9 BEDSIDE MONITOR (BSM) DURING A SURGICAL PROCEDURE. NK CAS CONFIRMED THE NMT SMART POD'S VALUE REACHED THE ALARM LEVEL LIMIT VALUE, BUT NO ALARM WAS TRIGGERED EVEN IN ALARM EVENTS. NO PATIENT HARM WAS REPORTED. NK CAS COPIED ALL CLINICAL SETTINGS FROM A KNOWN WORKING NMT SMART POD, TOF DEVICE BUT THE ISSUE PERSISTED. NK CAS CONCLUDED THAT IT WAS NOT THE G9 BEDSIDE MONITOR (BSM) THAT HAD THE ISSUE, IT WAS AN ISSUE WITH THE NMT SMART POD, TOF AND FURTHER INVESTIGATION IS ON-GOING BY NK. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: ATTEMPT # 1: 02/09/2024 EMAILED NIHON KOHDEN CLINICAL APPLICATION SPECIALIST VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/13/2024 EMAILED NIHON KOHDEN CLINICAL APPLICATION SPECIALIST VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 02/28/2024 EMAILED NIHON KOHDEN CLINICAL APPLICATION SPECIALIST VIA MICROSOFT OUTLOOK FOR INFORMATION IN THE NI LIST ABOVE: REPLY WAS RECEIVED FROM NKCAS WHO STATED "WE HAVE CONCLUDED THAT THE ISSUE WAS NOT WITH THE G9 BEDSIDE MONITOR. THE ISSUE WAS WITH THE NMT SMART POD, TOF DEVICE. THE ONLY PATIENT DEMOGRAPHICS THE CAS COULD PROVIDE WAS THAT THE PATIENT WAS MALE, 80 KG, UNDERGOING LAPARSCOPIC RIGHT INGUINAL HERNIA REPAIR". ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE NMT SMART POD, TOF DEVICE: BEDSIDE MONITOR (BSM): MODEL #: CU-192RA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 01/15/2021 UNIQUE IDENTIFIER (UDI) #: (B)(4) RETURNED TO NIHON KOHDEN: NA

Additional Manufacturer Narrative

INCIDENT SUMMARY: NIHON KOHDEN CLINICAL APPLICATION SPECIALIST (NKCAS) WAS ON-SITE WHEN THE ISSUE OCCURRED THAT THE G9 MONITOR DID NOT ALARM FOR THE TOF ALARM (TRAIN OF FOUR) WHEN USING THIS NMT SMART POD, TOF DEVICE WITH A G9 BEDSIDE MONITOR (BSM) DURING A SURGICAL PROCEDURE. NK CAS CONFIRMED THE NMT SMART POD'S VALUE REACHED THE ALARM LEVEL LIMIT VALUE, BUT NO ALARM WAS TRIGGERED EVEN IN ALARM EVENTS. NO PATIENT HARM WAS REPORTED. NK CAS COPIED ALL CLINICAL SETTINGS FROM A KNOWN WORKING NMT SMART POD, TOF DEVICE BUT THE ISSUE PERSISTED. NK CAS CONCLUDED THAT IT WAS NOT THE G9 BEDSIDE MONITOR (BSM) THAT HAD THE ISSUE, IT WAS AN ISSUE WITH THE NMT SMART POD, TOF AND FURTHER INVESTIGATION IS ON-GOING BY NK. INVESTIGATION SUMMARY: NIHON KOHDEN CORPORATION REVIEWED THE VIDEO OF THE EVENT REPORTED AND FOUND THIS SEEMS TO BE THE INTENDED BEHAVIOR OF THE NMT SMART POD, TOF (TRAIN OF FOUR) COUNT ALARMS ARE NOT GENERATED DURING PROGRAM MODE AND DOES NOT HAVE AN AUTOMATIC ALARM FOR TOF. USER MUST MANUALLY SET WHEN NEEDED. USER MUST REFER TO THE OPERATOR'S MANUAL TO SET THE ALARM WHEN THE SIMULATION MODE OF [TOF] COUNT IS REQUIRED TO BE SET TO ON FOR THE SPECIFIC PATIENT BEING MONITORED. DEVICE IS WORKING AS DESIGNED. NIHON KOHDEN WILL CONTINUE TO MONITOR THIS REPORTED ISSUE. ADVISED THE CUSTOMER TO PLEASE CHECK THE OPERATORS MANUAL WHEN USING THE PRODUCT. ATTEMPT # 1: 02/09/2024 EMAILED NIHON KOHDEN CLINICAL APPLICATION SPECIALIST VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 02/13/2024 EMAILED NIHON KOHDEN CLINICAL APPLICATION SPECIALIST VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 02/28/2024 EMAILED NIHON KOHDEN CLINICAL APPLICATION SPECIALIST VIA MICROSOFT OUTLOOK FOR INFORMATION IN THE NI LIST ABOVE: REPLY WAS RECEIVED FROM NKCAS WHO STATED "WE HAVE CONCLUDED THAT THE ISSUE WAS NOT WITH THE G9 BEDSIDE MONITOR. THE ISSUE WAS WITH THE NMT SMART POD, TOF DEVICE. THE ONLY PATIENT DEMOGRAPHICS THE CAS COULD PROVIDE WAS THAT THE PATIENT WAS MALE, 80 KG, UNDERGOING LAPARSCOPIC RIGHT INGUINAL HERNIA REPAIR". ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE NMT SMART POD, TOF DEVICE: THERE WAS NO REPORTED ISSUES WITH THIS DEVICE. BEDSIDE MONITOR (BSM): MODEL #: CU-192RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 01/15/2021. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA.

Description of Event or Problem

NIHON KOHDEN CLINICAL APPLICATION SPECIALIST (NKCAS) WAS ON-SITE WHEN THE ISSUE OCCURRED THAT THE G9 MONITOR DID NOT ALARM FOR THE TOF ALARM (TRAIN OF FOUR) WHEN USING THIS NMT SMART POD, TOF DEVICE WITH A G9 BEDSIDE MONITOR (BSM) DURING A SURGICAL PROCEDURE. NK CAS CONFIRMED THE NMT SMART POD'S VALUE REACHED THE ALARM LEVEL LIMIT VALUE, BUT NO ALARM WAS TRIGGERED EVEN IN ALARM EVENTS. NO PATIENT HARM WAS REPORTED. NK CAS COPIED ALL CLINICAL SETTINGS FROM A KNOWN WORKING NMT SMART POD, TOF DEVICE BUT THE ISSUE PERSISTED. NK CAS CONCLUDED THAT IT WAS NOT THE G9 BEDSIDE MONITOR (BSM) THAT HAD THE ISSUE, IT WAS AN ISSUE WITH THE NMT SMART POD, TOF AND FURTHER INVESTIGATION IS ON-GOING BY NK.