ORG-9110A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WERE COMMUNICATION LOSS ERRORS FOR ALL TELEMETRY TRANSMITTERS EVERY 6 MINUTES FOR 30 SECONDS. THEY REBOOTED THE MULTIPLE PATIENT RECEIVER (ORG) BUT THAT DID NOT RESOLVE THE ISSUE. THE CUSTOMER SWAPPED THIS UNIT WITH A SPARE ORG, AND THE ISSUE WENT AWAY IMMEDIATELY AND DID NOT RETURN. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WERE COMMUNICATION LOSS ERRORS FOR ALL TELEMETRY TRANSMITTERS EVERY 6 MINUTES FOR 30 SECONDS. THEY REBOOTED THE MULTIPLE PATIENT RECEIVER (ORG) BUT THAT DID NOT RESOLVE THE ISSUE. THE CUSTOMER SWAPPED THIS UNIT WITH A SPARE ORG, AND THE ISSUE WENT AWAY IMMEDIATELY AND DID NOT RETURN. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED THAT THERE WERE COMMUNICATION LOSS ERRORS FOR ALL TELEMETRY TRANSMITTERS. ROUTINE TROUBLESHOOTING DID NOT RESOLVE THE ISSUE, AND THE COMPLAINT ORG RECEIVER WAS RETURNED TO NIHON KOHDEN FOR EVALUATION AND REPAIR. THE REPORTED ISSUE WAS DUPLICATED, AND AN INVALID CRC-32 WAS OBSERVED DURING DIAGNOSTIC TESTING. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE FAULT IN THE UR-3981 CPU BOARD. AFTER REPLACEMENT OF THE MALFUNCTIONING COMPONENT, THE DEVICE OPERATED TO MANUFACTURER'S SPECIFICATIONS. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY REVEALS THREE SIMILAR ISSUES IN TICKETS (B)(4). REGARDING TICKET (B)(4), THE CUSTOMER RESOLVED THE ISSUE OF COMMUNICATION LOSS IN-HOUSE. THE ISSUES OF COMMUNICATION LOSS IN TICKETS (B)(4), REPORTED IN AUGUST 2024 AND SEPTEMBER 2025, RESPECTIVELY, WERE NOT REPLICATED DURING EVALUATION AT NIHON KOHDEN, AND THEREFORE DID NOT ESTABLISH DEFINITIVE ROOT CAUSES. THE COMPLAINT DEVICE HAD BEEN INSTALLED AT THE CUSTOMER FACILITY SINCE APRIL 2015. IT'S POSSIBLE THAT THE FAILURE OF THE UR-3981 CPU BOARD WAS RELATED TO AGE OR ACCUMULATED WEAR AND TEAR. ADDITIONAL DEVICE INFORMATION: D10: CONCOMITANT MEDICAL DEVICE: CENTRAL NURSE'S STATION: MODEL: PU-621R, SN: (B)(6). TELEMETRY TRANSMITTER: MODEL: ZM-531PA, SN: (B)(6). TELEMETRY TRANSMITTER: MODEL: ZM-531PA, SN: (B)(6). TELEMETRY TRANSMITTER: MODEL: ZM-531PA, SN: (B)(6). 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.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WERE COMMUNICATION LOSS ERRORS FOR ALL TELEMETRY TRANSMITTERS EVERY 6 MINUTES FOR 30 SECONDS. THEY REBOOTED THE MULTIPLE PATIENT RECEIVER (ORG) BUT THAT DID NOT RESOLVE THE ISSUE. THE CUSTOMER SWAPPED THIS UNIT WITH A SPARE ORG, AND THE ISSUE WENT AWAY IMMEDIATELY AND DID NOT RETURN. 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: CENTRAL NURSE'S STATION MODEL: PU-621R SN: (B)(6). TELEMETRY TRANSMITTER MODEL: ZM-531PA SN: (B)(6). TELEMETRY TRANSMITTER MODEL: ZM-531PA SN: (B)(6). TELEMETRY TRANSMITTER MODEL: ZM-531PA SN: (B)(6).

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WERE COMMUNICATION LOSS ERRORS FOR ALL TELEMETRY TRANSMITTERS EVERY 6 MINUTES FOR 30 SECONDS. THEY REBOOTED THE MULTIPLE PATIENT RECEIVER (ORG) BUT THAT DID NOT RESOLVE THE ISSUE. THE CUSTOMER SWAPPED THIS UNIT WITH A SPARE ORG, AND THE ISSUE WENT AWAY IMMEDIATELY AND DID NOT RETURN. NO PATIENT HARM WAS REPORTED.