ORG-9110A

Additional Manufacturer Narrative

DETAILS OF THE COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS GOING INTO COMMUNICATION LOSS AND HAVING POWER ISSUES. WHEN THIS OCCURS, ALL 8 TELEMETRY TRANSMITTERS ASSIGNED TO THIS ORG WILL GO INTO COMM LOSS. SOMETIMES IT WILL COME OUT OF COMM LOSS BY ITSELF. OTHER TIMES, THEY HAVE TO POWER CYCLE THE ORG. ADDITIONALLY, THEY HAVE WITNESSED THE ORG POWERING ITSELF OFF AND BACK ON AGAIN. THE POWER CABLE WAS CHECKED AND IS WORKING. THEY PUT A SPARE ORG IN PLACE OF THIS ONE, AND THAT ONE HAS BEEN RUNNING FINE WITH NO ISSUES. THEY HAVE DECIDED TO PURCHASE A NEW ORG TO REPLACE THIS ONE. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: ROOT CAUSE ANALYSIS: WE WERE UNABLE TO CONFIRM THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BUT BASED ON THE AVAILABLE INFORMATION THE MOST PROBABLE ROOT CAUSE WAS POTENTIALLY CAUSED BY SOFTWARE CORRUPTION OR COMPONENT FAILURE. THE CUSTOMER DECIDED TO PURCHASE A NEW UNIT TO RESOLVE THE ISSUE. OTHER POTENTIAL CAUSES OF COMM LOSS AND POWER LOSS ARE LISTED BELOW: POTENTIAL CAUSE(S)/MITIGATION OF ISSUES: WE HAVE IDENTIFIED SOME ORG ISSUES, WHICH ARE NOT LIMITED TO, USER RELATED ERROR, INCORRECT SETTINGS, INSTALLATION ISSUES, FILE OR SOFTWARE CORRUPTION, (DUE TO A USER RELATE ERROR, SUCH AS AN UNGRACEFUL EXIT OR SHUTDOWN, WHICH CAN CAUSE CORRUPTION AND SETTING RELATED ISSUES), BATTERY ISSUES, HARDWARE/COMPONENT FAILURE ISSUES, CUSTOMER FACILITY IT (INFORMATION TECHNOLOGY) ISSUES OR NETWORK ENVIRONMENTAL ISSUES (INCLUDING POWER SUPPLY OR POWER PLUG IN OUTLET ISSUES). ISSUES WITH ORG DEVICES CAN BE MITIGATED BY OUR NK TS TEAM WORKING WITH THE CUSTOMER, OR THE CUSTOMER WORKING WITH THEIR IT DEPARTMENT TO RESOLVE ANY USER RELATED SETUP ERRORS OR ISSUES. IF THE ISSUE IS DETERMINED TO BE RELATED TO DAMAGE, THE DAMAGED DEVICE, COMPONENT AND OR ACCESSORIES/CABLE OR HARDWARE USED WITH THE DEVICE, CAN BE EITHER REPAIRED OR REPLACED TO RESOLVE ANY DAMAGE ISSUES. SPONTANEOUS REBOOT OVERVIEW: SPONTANEOUS REBOOT OR SHUTDOWN ARE USUALLY REPORTED WHILE THE ORG IS MONITORING PATIENTS. THERE ARE A NUMBER OF FACTORS THAT MAY TRIGGER A SPONTANEOUS REBOOT/SHUTDOWN: · POWER OUTAGE · UNINTERRUPTABLE POWER SUPPLY (UPS) FAILURE · LOOSE POWER CABLE · ORG OVERHEATING · ORG POWER SUPPLY FAILURE · ORG MOTHERBOARD FAILURE · ORG HARD DRIVE FAILURE WHEN THE USER ATTEMPTS TO POWER THE ORG BACK UP, OR THE ORG REBOOTS ITSELF, THE FOLLOWING ARE POSSIBLE SYMPTOMS: · DOES NOT POWER ON · INCOMPLETE BOOT UP SEQUENCE · BOOTED UP INTO WINDOWS, BUT WILL NOT LOAD ORG APPLICATION · DISPLAYS NETWORK DISCONNECT. ASIDE FROM LESS COMMON CAUSES OF ORG POWER SUPPLY OR MOTHERBOARD FAILURE, BOOT UP FAILURE, INCLUDING BOOT LOOPING, BOOTING INTO BIOS, FAILURE TO LOAD ORG APPLICATION, AND FAILURE TO COMPLETE THE BOOT UP CYCLE ARE COMMONLY CAUSED BY HARD DRIVE FAILURE. DEVICE HISTORY: A SERIAL NUMBER REVIEW OF THE REPORTED DEVICE (MODEL: ORG-9110A, SERIAL NUMBER: (B)(6)) DOES NOT REVEAL ADDITIONAL RELATED COMPLAINTS. COMPLAINT HISTORY REVIEW OF THE CUSTOMER'S ACCOUNT DOES NOT REVEAL TRENDS FOR SIMILAR COMPLAINTS. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE ATTEMPT #1 (B)(6) 2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK AND PROVIDED SOME OF THE DEVICE INFORMATION. CENTRAL NURSE'S STATION. MODEL: NI. SN: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER(S) MODEL: ZM-531PA. SN: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS GOING INTO COMMUNICATION LOSS AND HAVING POWER ISSUES. WHEN THIS OCCURS, ALL 8 TELEMETRY TRANSMITTERS ASSIGNED TO THIS ORG WILL GO INTO COMM LOSS. SOMETIMES IT WILL COME OUT OF COMM LOSS BY ITSELF. OTHER TIMES, THEY HAVE TO POWER CYCLE THE ORG. ADDITIONALLY, THEY HAVE WITNESSED THE ORG POWERING ITSELF OFF AND BACK ON AGAIN. THE POWER CABLE WAS CHECKED AND IS WORKING. THEY PUT A SPARE ORG IN PLACE OF THIS ONE, AND THAT ONE HAS BEEN RUNNING FINE WITH NO ISSUES. THEY HAVE DECIDED TO PURCHASE A NEW ORG TO REPLACE THIS ONE. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS GOING INTO COMMUNICATION LOSS AND HAVING POWER ISSUES. WHEN THIS OCCURS, ALL 8 TELEMETRY TRANSMITTERS ASSIGNED TO THIS ORG WILL GO INTO COMM LOSS. SOMETIMES IT WILL COME OUT OF COMM LOSS BY ITSELF. OTHER TIMES, THEY HAVE TO POWER CYCLE THE ORG. ADDITIONALLY, THEY HAVE WITNESSED THE ORG POWERING ITSELF OFF AND BACK ON AGAIN. THE POWER CABLE WAS CHECKED AND IS WORKING. THEY PUT A SPARE ORG IN PLACE OF THIS ONE, AND THAT ONE HAS BEEN RUNNING FINE WITH NO ISSUES. THEY HAVE DECIDED TO PURCHASE A NEW ORG TO REPLACE THIS ONE. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS GOING INTO COMMUNICATION LOSS AND HAVING POWER ISSUES. WHEN THIS OCCURS, ALL 8 TELEMETRY TRANSMITTERS ASSIGNED TO THIS ORG WILL GO INTO COMM LOSS. SOMETIMES IT WILL COME OUT OF COMM LOSS BY ITSELF. OTHER TIMES, THEY HAVE TO POWER CYCLE THE ORG. ADDITIONALLY, THEY HAVE WITNESSED THE ORG POWERING ITSELF OFF AND BACK ON AGAIN. THE POWER CABLE WAS CHECKED AND IS WORKING. THEY PUT A SPARE ORG IN PLACE OF THIS ONE, AND THAT ONE HAS BEEN RUNNING FINE WITH NO ISSUES. THEY HAVE DECIDED TO PURCHASE A NEW ORG TO REPLACE THIS ONE. 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. THE FOLLOWING FIELDS CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT THE INFORMATION WAS NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE. ATTEMPT #1 (B)(6) 2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK AND PROVIDED SOME OF THE DEVICE INFORMATION. CENTRAL NURSE'S STATION: MODEL: NI. SN: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER(S): MODEL: ZM-531PA. SN: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED.