NI

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEIR SWITCH IS BLINKING AMBER AND GREEN, WHILE THE OTHER SWITCHES ARE BLINKING GREEN ONLY. THE NETWORKING TEAM MANAGER WORKED WITH THE CUSTOMER AND FOUND OUT THAT AFTER THE CUSTOMER REPLACED THE ORG WITH A SPARE UNIT, THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THEIR SWITCH IS BLINKING AMBER AND GREEN, WHILE THE OTHER SWITCHES ARE BLINKING GREEN ONLY. ACCORDING TO THE CUSTOMER, THE ISSUE WAS DISCOVERED AFTER ALL TELEMETRY UNITS BRIEFLY DISAPPEARED FROM THE CENTRAL NURSE'S STATION (CNS) AND THEN RETURNED. THE NETWORKING TEAM MANAGER WORKED WITH THE CUSTOMER AND FOUND OUT THAT AFTER THE CUSTOMER REPLACED THE ORG WITH A SPARE UNIT, THE ISSUE WAS RESOLVED. 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. THE FOLLOWING FIELDS CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D1 D4 MODEL NUMBER CATALOG NUMBER SERIAL NUMBER LOT NUMBER EXPIRATION DATE UNIQUE IDENTIFIER (UDI) NUMBER. D10 ATTEMPT # 1: 03/16/2026 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 03/18/2026 I CALLED KAVITHA TO ASK FOR THE MODEL AND SERIAL NUMBER FOR THE ORG AND MODEL AND SERIAL NUMBERS FOR ANY DEVICE(S) THE ORG WAS CONNECTED OR RELATED TO. A MESSAGE WAS LEFT FOR KAVITHA TO CALL ME BACK WITH THIS INFORMATION. ATTEMPT # 3: 03/20/2025 I CALLED KAVITHA TO ASK FOR THE MODEL AND SERIAL NUMBER FOR THE ORG AND MODEL AND SERIAL NUMBERS FOR ANY DEVICE(S) THE ORG WAS CONNECTED OR RELATED TO. A MESSAGE WAS LEFT FOR KAVITHA TO CALL ME BACK WITH THIS INFORMATION. THE FOLLOWING FIELDS ARE NOT AVAILABLE (N/A) TO THIS REPORT: H4 DEVICE MANUFACTURER DATE.