ORG-9110A

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) DISAPPEARED FROM THE CENTRAL NURSE'S STATION (CNS). AN ERROR LIGHT WAS LIT ON THE ORG AND NONE OF THE TELEMETRY TRANSMITTERS OR RECEIVER CARDS WERE VISIBLE ON THE NETWORK. TECHNICAL SUPPORT (TS) HAD HIM POWER OFF THE ORG FOR 5 MINUTES, BUT THE ISSUE PERSISTED. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) DISAPPEARED FROM THE CENTRAL NURSE'S STATION (CNS). AN ERROR LIGHT WAS LIT ON THE ORG AND NONE OF THE TELEMETRY TRANSMITTERS OR RECEIVER CARDS WERE VISIBLE ON THE NETWORK. TECHNICAL SUPPORT (TS) HAD HIM POWER OFF THE ORG FOR 5 MINUTES, BUT THE ISSUE PERSISTED. THIS DEVICE WAS REPAIRED IN TICKET #(B)(4) FOR THE SAME ISSUE 3 MONTHS PRIOR TO THIS COMPLAINT. 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: (B)(6) 2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: (B)(6) 2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: (B)(6) 2025 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR THE INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) DISAPPEARED FROM THE CENTRAL NURSE'S STATION (CNS). AN ERROR LIGHT WAS LIT ON THE ORG AND NONE OF THE TELEMETRY TRANSMITTERS OR RECEIVER CARDS WERE VISIBLE ON THE NETWORK. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) DISAPPEARED FROM THE CENTRAL NURSE'S STATION (CNS). AN ERROR LIGHT WAS LIT ON THE ORG AND NONE OF THE TELEMETRY TRANSMITTERS OR RECEIVER CARDS WERE VISIBLE ON THE NETWORK. TECHNICAL SUPPORT (TS) HAD HIM POWER OFF THE ORG FOR 5 MINUTES, BUT THE ISSUE PERSISTED. THIS DEVICE WAS REPAIRED IN TICKET # (B)(4) FOR THE SAME ISSUE 3 MONTHS PRIOR TO THIS COMPLAINT. NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS SENT IN FOR EVALUATION AND EXCHANGE. THE DEVICE WAS INSPECTED, CLEANED, AND EVALUATED WITH NO SIGNS OF PHYSICAL DAMAGE OR FLUID EXPOSURE. THE REPORTED ERROR LIGHT WAS DUPLICATED DURING TESTING, AND FURTHER TROUBLESHOOTING DETERMINED THAT THE CPU BOARD (UR-3981) HAD FAILED, REQUIRING REPLACEMENT. THE ROOT CAUSE WAS DETERMINED TO BE AN INTERNAL COMPONENT FAILURE OF THE CPU BOARD. THE DEVICE WAS INSTALLED ON (B)(6) 2021. WEAR AND TEAR IS LIKELY A CONTRIBUTING FACTOR. NK WILL CONTINUE TO MONITOR AND TREND. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE? H6 EVENT PROBLEM AND EVALUATION CODES. H11 ADDITIONAL MANUFACTURER NARRATIVE.