ORG-9110A

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT WHEN THEY DO A PATIENT TRANSFER, THE ORG FALLS OFF THE NETWORK AND THEY'RE UNABLE TO TRANSFER ANY PATIENTS. ACCORDING TO THE CUSTOMER, AFTER A REBOOT, THE ORG WILL CONTINUE TO WORK WITHOUT ISSUE. TECHNICAL SUPPORT (TS) ASKED THE CUSTOMER TO DISCONNECT THE ORG FROM THE NETWORK AND CHECK TO SEE IF THERE WERE ANY DUPLICATE IPS. THE CUSTOMER DID THAT AND CONFIRMED THAT NO DUPLICATE IPS WERE FOUND. TS DISCOVERED THAT THIS UNIT WAS SENT IN FOR REPAIR (166530) FOR WHICH THE CUSTOMER SENT ALL THE CORRECT INFORMATION; HOWEVER, TS HAD A TYPO IN THE DEFAULT GATEWAY (GW). THE CUSTOMER WILL SEND IN THE UNIT TO BE EXCHANGED. THERE WAS NO PATIENT INJURY 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.

Description of Event or Problem

THE CUSTOMER REPORTED THAT WHEN THEY DO A PATIENT TRANSFER, THE ORG FALLS OFF THE NETWORK AND THEY'RE UNABLE TO TRANSFER ANY PATIENTS. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT WHEN THEY DO A PATIENT TRANSFER, THE ORG FALLS OFF THE NETWORK AND THEY'RE UNABLE TO TRANSFER ANY PATIENTS. ACCORDING TO THE CUSTOMER, AFTER A REBOOT, THE ORG WILL CONTINUE TO WORK WITHOUT ISSUE. TECHNICAL SUPPORT (TS) ASKED THE CUSTOMER TO DISCONNECT THE ORG FROM THE NETWORK AND CHECK TO SEE IF THERE WERE ANY DUPLICATE IPS. THE CUSTOMER DID THAT AND CONFIRMED THAT NO DUPLICATE IPS WERE FOUND. TS DISCOVERED THAT THIS UNIT WAS SENT IN FOR REPAIR (B)(4) FOR WHICH THE CUSTOMER SENT ALL THE CORRECT INFORMATION; HOWEVER, TS HAD A TYPO IN THE DEFAULT GATEWAY (GW). THE CUSTOMER WILL SEND IN THE UNIT TO BE EXCHANGED. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: THE REPORTED ISSUE WAS DUPLICATED AND CONFIRMED. UPON EVALUATION FROM THE REPAIR CENTER, THERE WAS A TYPO IN THE GATEWAY IP ADDRESS (192.168.226.1) WHICH WAS SET INCORRECTLY FROM NK TECHNICIAN. THE DEVICE WAS SET TO THE CORRECT IP 192.168.225.1 AND SHIPPED BACK TO THE CUSTOMER TO RESOLVE THE ISSUE. UDI RELATED DATA QUALITY UPDATES. 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 REPORTED THAT WHEN THEY DO A PATIENT TRANSFER, THE ORG FALLS OFF THE NETWORK AND THEY'RE UNABLE TO TRANSFER ANY PATIENTS. THERE WAS NO PATIENT INJURY REPORTED.