ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE SHOWING COMMUNICATION LOSS. THEY REBOOTED THE MULTIPLE PATIENT RECEIVER (ORG). THE UNIT CAME BACK UP, BUT IT WENT BACK INTO COMMUNICATION LOSS A FEW MOMENTS LATER. THIS WOULD AFFECT MONITORING OF PATIENTS ON TELEMETRY TRANSMITTERS. 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: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE(S) WERE BEING USED IN CONJUNCTION WITH THE ORG, BUT MODEL AND SERIAL NUMBER INFORMATION WAS NOTED AS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE BUT INFORMATION WAS NOT PROVIDED. CENTRAL NURSE'S STATION: MODEL: NI. SN: NI. TELEMETRY TRANSMITTER(S): MODEL: NI. SN: NI.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE SHOWING COMMUNICATION LOSS. THEY REBOOTED THE MULTIPLE PATIENT RECEIVER (ORG). THE UNIT CAME BACK UP, BUT IT WENT BACK INTO COMMUNICATION LOSS A FEW MOMENTS LATER. THIS WOULD AFFECT MONITORING OF PATIENTS ON TELEMETRY TRANSMITTERS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN COMMUNICATION LOSS WITH THE TELEMETRY TRANSMITTERS. THEY REBOOTED THE ORG, BUT IT WENT BACK INTO COMMUNICATION LOSS AFTER A FEW MOMENTS. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE DEVICE WAS SENT IN FOR REPAIR. DURING THE EVALUATION, NIHON KOHDEN REPAIR CENTER (NK RC) COULD NOT DUPLICATE THE COMPLAINT. PHYSICAL DAMAGE WAS FOUND ON THE ORG STAND. NK RC REPLACED THE GROUND PLATE, AND THE UNIT WAS TESTED PER THE SERVICE MANUAL AND OPERATES TO MANUFACTURER SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE COMPLAINT COULD NOT BE DUPLICATED. POSSIBLE CAUSES OF COMMUNICATION LOSS FROM THE ORG MAY INCLUDE INCOMPATIBLE SOFTWARE VERSIONS BETWEEN THE ORG AND CNS, OR USER ERROR REGARDING THE ORG'S NETWORK SETTINGS, SUCH AS AN INCORRECT NETWORK COMMUNICATION PROTOCOL. THE CUSTOMER SHOULD ENSURE DEVICES WITHIN THE PATIENT MONITORING NETWORK HAVE COMPATIBLE SOFTWARE VERSIONS AND ARE ON THE SAME NET PROTOCOL SETTING. A REVIEW OF THE DEVICE'S SERIAL NUMBER DOES NOT SHOW ANY OTHER COMPLAINTS.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN COMMUNICATION LOSS WITH THE TELEMETRY TRANSMITTERS. THEY REBOOTED THE ORG, BUT IT WENT BACK INTO COMMUNICATION LOSS AFTER A FEW MOMENTS. NO PATIENT HARM WAS REPORTED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS IN COMMUNICATION LOSS WITH THE TELEMETRY TRANSMITTERS. THEY REBOOTED THE ORG, BUT IT WENT BACK INTO COMMUNICATION LOSS AFTER A FEW MOMENTS. 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.