ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WITH SIX ZM TRANSMITTERS WERE IN COMM LOSS AT THE CENTRAL NURSE STATION (CNS). TECHNICAL SUPPORT (TS) INSTRUCTED THEM TO PERFORM A 2-MINUTE POWER CYCLE, RESEAT THE POWER CORD AND SWITCH THE ETHERNET CABLE TO ANOTHER PORT ON THE SWITCH, BUT THE ISSUE PERSISTED AND THE LINK LIGHTS WERE SOLID ORANGE. 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 DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NA.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WITH SIX ZM TRANSMITTERS WERE IN COMM LOSS AT THE CENTRAL NURSE STATION (CNS). NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WITH SIX ZM TRANSMITTERS WERE IN COMM LOSS AT THE CENTRAL NURSE STATION (CNS). NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WITH SIX ZM TRANSMITTERS WERE IN COMM LOSS AT THE CENTRAL NURSE STATION (CNS). TECHNICAL SUPPORT (TS) INSTRUCTED THEM TO PERFORM A 2-MINUTE POWER CYCLE, RESEAT THE POWER CORD AND SWITCH THE ETHERNET CABLE TO ANOTHER PORT ON THE SWITCH, BUT THE ISSUE PERSISTED AND THE LINK LIGHTS WERE SOLID ORANGE. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED AN ORG RECEIVER WITH COMMUNICATION LOSS AND AN ERROR LIGHT. THE ISSUE COULD NOT BE RESOLVED THROUGH TROUBLESHOOTING, AND THE CUSTOMER WAS PRESENTED WITH THE OPTIONS OF A BILLABLE REPAIR OR EXCHANGE. A DEFINITIVE ROOT CAUSE FOR THE EVENT CANNOT BE ESTABLISHED BECAUSE THE CUSTOMER DID NOT RESPOND TO ATTEMPTS TO FACILITATE DEVICE RETURN. AGING HARDWARE MAY HAVE BEEN A CONTRIBUTING FACTOR, AS THE DEVICE HAD BEEN INSTALLED AT THE CUSTOMER FACILITY SINCE JULY 2016. A REVIEW OF THE CUSTOMER'S SALES ORDERS INDICATES THAT THE CUSTOMER ORDERED A NEW ORG-9110A (SALES ORDER (B)(4)) APPROXIMATELY A WEEK AFTER COMPLAINT REPORTING. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY BY SERIAL NUMBER REVEALS TWO SIMILAR ISSUES FOR WHICH THE DEVICE WAS RETURNED FOR REPAIR IN TICKETS (B)(4). THE ROOT CAUSE OF THESE EVENTS WAS DETERMINED TO BE SOFTWARE RELATED. A SIGNIFICANT TREND HAS NOT BEEN OBSERVED THAT WOULD WARRANT ANY FURTHER CORRECTIVE ACTION. NIHON KOHDEN WILL CONTINUE TO TREND AND MONITOR. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: NI, SERIAL #: NI, DEVICE MANUFACTURER DATA: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NA. ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT, G3. DATE RECEIVED BY MANUFACTURER, G6. TYPE OF REPORT, H2. IF FOLLOW-UP, WHAT TYPE? H6. EVENT PROBLEM AND EVALUATION CODES, H11. ADDITIONAL MANUFACTURER NARRATIVE.