ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS INTERMITTENTLY GOING INTO COMM LOSS AT THE CENTRAL NURSE'S STATION (CNS). THERE WERE NO ERROR LEDS ON THE ORG, AND THEY REBOOTED IT, BUT THE ISSUE RETURNED ON 03/26/2025. THEY TIGHTENED THE COAX CABLE; HOWEVER, IT WENT INTO COMM LOSS AGAIN A FEW HOURS LATER. 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. THE FOLLOWING FIELD CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 04/07/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 04/21/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 04/23/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: PU-681RA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 04/12/2022 (APRIL 12, 2022), UNIQUE IDENTIFIER (UDI) #: (B)(4), 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) WAS INTERMITTENTLY GOING INTO COMM LOSS AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS INTERMITTENTLY GOING INTO COMM LOSS AT THE CENTRAL NURSE'S STATION (CNS). THERE WERE NO ERROR LEDS ON THE ORG, AND THEY REBOOTED IT, BUT THE ISSUE RETURNED ON (B)(6) 2025. THEY TIGHTENED THE COAX CABLE; HOWEVER, IT WENT INTO COMM LOSS AGAIN A FEW HOURS LATER. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED. THE UNIT WAS EVALUATED AND THE COMPLAINT OF "COMMUNICATION LOSS" IS DUPLICATED. THE UNIT KEPT REBOOTING WITH ERROR LED WAS ON. THE CAUSE WAS SOFTWARE CORRUPTION. NO FURTHER INVESTIGATION WILL BE PERFORMED. NK WILL CONTINUE TO MONITOR AND TREND. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE ORG: CNS: MODEL #: PU-681RA SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: 04/12/2022 (APRIL 12, 2022) UNIQUE IDENTIFIER (B)(4() RETURNED TO NIHON KOHDEN: NA. ZM TRANSMITTERS: MODEL #: NI SERIAL #: (B)(6) DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #:(B)(4) 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? H3 DEVICE EVALUATED BY MANUFACTURER H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS INTERMITTENTLY GOING INTO COMM LOSS AT THE CENTRAL NURSE'S STATION (CNS). NO PATIENT HARM WAS REPORTED.