ORG-9100A

Additional Manufacturer Narrative

DETAILS OF THE COMPLAINT: THE CUSTOMER IT / IS REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS IN COMMUNICATION LOSS. THE ORG WAS REBOOTED, BUT THERE IS AN ERROR LIGHT ON THIS UNIT. THE WAS SENT IN FOR EVALUATION, BUT THE ISSUE COULD NOT BE DUPLICATED AND RETURNED TO THEM. HOWEVER, IT IS HAVING ISSUES AGAIN. THE UNIT CAME IN FOR EVALUATION AGAIN, BUT THE COMMUNICATION LOSS AND THE ERROR LIGHT ISSUE COULD NOT BE DUPLICATED. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: NIHON KOHDEN (NK) RECEIVED THE COMPLAINT DEVICE ON 09/06/2023. NK REPAIR CENTER (RC) EVALUATED THE UNIT ON 09/28/2023 AND COULD NOT DUPLICATE THE COMPLAINT. NO PHYSICAL DAMAGE OR FLUID INTRUSION OBSERVED. NK RC FOUND THAT THE ERROR LIGHT WAS ON WHEN THE ORG WAS TURNED ON. NK RC RE-INITIALIZED THE UNIT AND RAN A DIAGNOSTIC CHECK. AFTER INITIALIZATION, THE UNIT WAS TESTED OVER 10 DAYS WITH A SIMULATOR AND DID NOT SHOW ANY COMMUNICATION LOSS OR AN ERROR LIGHT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE WE COULD NOT DUPLICATE THE COMPLAINT DURING EVALUATION. POSSIBLE CAUSES OF COMMUNICATION LOSS FOR THE ORG MAY INCLUDE INCOMPATIBLE SOFTWARE VERSIONS BETWEEN THE ORG AND CNS, OR USER ERROR WITH THE ORG'S NETWORK SETTINGS SUCH AS INCORRECT NETWORK COMMUNICATION PROTOCOL. THE CUSTOMER SHOULD ENSURE DEVICES WITHIN THE PATIENT MONITORING NETWORK ARE ON COMPATIBLE SOFTWARE VERSIONS AND ON THE SAME NET PROTOCOL SETTING. POSSIBLE CAUSE OF THE ERROR LIGHT MAY BE RELATED TO THE BACKUP RAM WHICH STORES SYSTEM SETTINGS. THE ORG-9100 SERVICE MANUAL RECOMMENDS INITIALIZATION TO TROUBLESHOOT ERROR LIGHTS RELATED TO THE BACKUP RAM. MEMORY PROCESSING COMPONENTS MAY BECOME CORRUPT DUE TO UNGRACEFUL SHUTDOWN, POWER OUTAGES, OR USER ERROR WHILE UPGRADING SOFTWARE. REVIEW OF THE COMPLAINT DEVICE'S SERIAL NUMBER SHOWS A PREVIOUS OCCURRENCE UNDER TICKET (B)(4) IN WHICH THE DEVICE WAS RETURNED FOR EVALUATION, BUT WE COULD NOT DUPLICATE THE COMPLAINT; THE UNIT WAS INITIALIZED TO FACTORY SETTINGS AND RETURNED TO THE CUSTOMER. REVIEW OF THE CUSTOMER'S COMPLAINT HISTORY SHOWS 1 SIMILAR COMPLAINT UNDER TICKET (B)(4) IN WHICH THE ISSUE WAS FOUND TO BE DUE TO THE ORG'S UPS NOT STAYING ON AFTER A GENERATOR TEST AT THE CUSTOMER SITE. FROM THE ORG-9100 OPERATOR'S MANUAL: WHEN THE FOLLOWING SETTINGS ARE SET ON THE ORG SETTING WINDOW OF THE CENTRAL MONITOR, ALL THE INSTRUMENTS IN THE NETWORK MUST HAVE COMPATIBLE SOFTWARE VERSIONS. ARRHYTHMIA TYPE IS SET TO EXTENDED. AVAILABLE ALARM TYPES IS SET TO ALL. PROTOCOL IS SET TO 2ND GEN. OTHERWISE, MONITORING IS NOT POSSIBLE ON ANY BEDSIDE MONITOR OR CENTRAL MONITOR WHICH HAS AN INCOMPATIBLE SOFTWARE VERSION. ADDITIONAL DEVICE INFORMATION: D10: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE ORG. CENTRAL NURSE'S STATION. MODEL: CNS-6201A. SN: (B)(6). DEVICE MANUFACTURER DATE: 10/27/2014 . UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER. MODEL: ZM-520PA. SN: (B)(6). DEVICE MANUFACTURER DATE: 07/09/2020. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE CUSTOMER IT / IS REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS IN COMMUNICATION LOSS. THE ORG WAS REBOOTED, BUT THERE IS AN ERROR LIGHT ON THIS UNIT. THE WAS SENT IN FOR EVALUATION, BUT THE ISSUE COULD NOT BE DUPLICATED AND RETURNED TO THEM. HOWEVER, IT IS HAVING ISSUES AGAIN. THE UNIT CAME IN FOR EVALUATION AGAIN, BUT THE COMMUNICATION LOSS AND THE ERROR LIGHT ISSUE COULD NOT BE DUPLICATED. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE CUSTOMER IT / IS REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS IN COMMUNICATION LOSS. THE ORG WAS REBOOTED, BUT THERE IS AN ERROR LIGHT ON THIS UNIT. THE WAS SENT IN FOR EVALUATION, BUT THE ISSUE COULD NOT BE DUPLICATED AND RETURNED TO THEM. HOWEVER, IT IS HAVING ISSUES AGAIN. THE UNIT CAME IN FOR EVALUATION AGAIN, BUT THE COMMUNICATION LOSS AND THE ERROR LIGHT ISSUE COULD NOT BE DUPLICATED. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES. CORRECTED INFORMATION: D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PI INFORMATION. CORRECTED THE UDI-PI # FROM (B)(4). THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A.

Description of Event or Problem

THE CUSTOMER IT / IS REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS IN COMMUNICATION LOSS. THE ORG WAS REBOOTED, BUT THERE IS AN ERROR LIGHT ON THIS UNIT. THE WAS SENT IN FOR EVALUATION, BUT THE ISSUE COULD NOT BE DUPLICATED AND RETURNED TO THEM. HOWEVER, IT IS HAVING ISSUES AGAIN. THE UNIT CAME IN FOR EVALUATION AGAIN, BUT THE COMMUNICATION LOSS AND THE ERROR LIGHT ISSUE COULD NOT BE DUPLICATED. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES. CORRECTED INFORMATION: D4 ADDITIONAL DEVICE INFORMATION / PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #: CORRECTED THE UDI # TO INCLUDE THE PI INFORMATION. THIS IS A CORRECTION TO THE SUSPECT MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A.

Description of Event or Problem

THE CUSTOMER IT / IS REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS IN COMMUNICATION LOSS. THE ORG WAS REBOOTED, BUT THERE IS AN ERROR LIGHT ON THIS UNIT. THE WAS SENT IN FOR EVALUATION, BUT THE ISSUE COULD NOT BE DUPLICATED AND RETURNED TO THEM. HOWEVER, IT IS HAVING ISSUES AGAIN. THE UNIT CAME IN FOR EVALUATION AGAIN, BUT THE COMMUNICATION LOSS AND THE ERROR LIGHT ISSUE COULD NOT BE DUPLICATED. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER IT / IS REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS IN COMMUNICATION LOSS. THE ORG WAS REBOOTED, BUT THERE IS AN ERROR LIGHT ON THIS UNIT. THE WAS SENT IN FOR EVALUATION, BUT THE ISSUE COULD NOT BE DUPLICATED AND RETURNED TO THEM. HOWEVER, IT IS HAVING ISSUES AGAIN. THE UNIT CAME IN FOR EVALUATION AGAIN, BUT THE COMMUNICATION LOSS AND THE ERROR LIGHT ISSUE COULD NOT BE DUPLICATED. 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(S) WERE BEING USED IN CONJUNCTION WITH THE ORG. CENTRAL NURSE'S STATION: MODEL: CNS-6201A. SN: (B)(6). DEVICE MANUFACTURER DATE: 10/27/2014. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER: MODEL: ZM-520PA. SN: (B)(6). DEVICE MANUFACTURER DATE: 07/09/2020 . UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED.