ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE SEEING ERROR LIGHTS ON THE MULTIPLE PATIENT RECEIVER (ORG), AND ALSO, THEY ARE UNABLE TO SEE THE ORG ON THE NETWORK. THE ISSUE WAS DISCOVERED WHILE IN-USE EARLIER TODAY, AND THE TELEMETRY TRANSMITTERS (TELES) WENT INTO COMM-LOSS, AND THEY WERE UNABLE TO SEE THEM AT ALL ON THE NETWORK AFTERWARDS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE SEEING ERROR LIGHTS ON THE MULTIPLE PATIENT RECEIVER (ORG), AND ALSO THEY ARE UNABLE TO SEE THE ORG ON THE NETWORK.. THE ISSUE WAS DISCOVERED WHILE IN-USE EARLIER TODAY, AND THE TELEMETRY TRANSMITTERS (TELES) WENT INTO COMM-LOSS, AND THEY WERE UNABLE TO SEE THEM AT ALL ON THE NETWORK AFTERWARDS. 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. CENTRAL NURSE'S STATION MODEL: PU-681RA, SN: (B)(6), UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER(S) MODEL: ZM-531PA, SN: (B)(6), UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NOT RETURNED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE SEEING ERROR LIGHTS ON THE MULTIPLE PATIENT RECEIVER (ORG), AND ALSO THEY ARE UNABLE TO SEE THE ORG ON THE NETWORK.. THE ISSUE WAS DISCOVERED WHILE IN-USE EARLIER TODAY, AND THE TELEMETRY TRANSMITTERS (TELES) WENT INTO COMM-LOSS, AND THEY WERE UNABLE TO SEE THEM AT ALL ON THE NETWORK AFTERWARDS. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY ARE SEEING ERROR LIGHTS ON THE MULTIPLE PATIENT RECEIVER (ORG), AND ALSO THEY ARE UNABLE TO SEE THE ORG ON THE NETWORK.. THE ISSUE WAS DISCOVERED WHILE IN-USE EARLIER TODAY, AND THE TELEMETRY TRANSMITTERS (TELES) WENT INTO COMM-LOSS, AND THEY WERE UNABLE TO SEE THEM AT ALL ON THE NETWORK AFTERWARDS. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED THAT THE ORG-9110A UNIT DISPLAYED ERROR LIGHTS AND COULD NOT BE SEEN ON THE NETWORK, RESULTING IN TELEMETRY COMMUNICATION LOSS. THE ISSUE WAS CONFIRMED AND DUPLICATED AT THE REPAIR CENTER. EVALUATION FOUND NO PHYSICAL DAMAGE OR FLUID INTRUSION. DIAGNOSTIC TESTING INDICATED THAT THE ERROR DID NOT CLEAR AFTER INITIALIZATION AND THAT NOTHING WAS DISPLAYED ON THE PC TERMINAL. PER THE SERVICE MANUAL, THE CAUSE WAS IDENTIFIED AS A UR-3981 CPU BOARD FAULT. THE UNIT WAS REPLACED UNDER WARRANTY WITH A REFURBISHED EXCHANGE UNIT. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING FIELD(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE. ATTEMPT #1 07/30/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER PROVIDED SOME OF THE DEVICE INFORMATION. CENTRAL NURSE'S STATION: MODEL: PU-681RA. SN: (B)(6). UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER(S): MODEL: ZM-531PA. SN: NI. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D9 DEVICE AVAILABLE FOR EVALUATION. 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.