ORG-9110A

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS AN ERROR LIGHT. THEY HAVE TRIED REBOOTING THE UNIT, AND IT STILL COMES UP WITH AN ERROR. THEY WOULD LIKE TO SEND THE DEVICE IN FOR REPAIR TO CLEAR THE ERROR. THEY WERE GETTING COMMUNICATION LOSS ERRORS ON THE CENTRAL NURSE'S STATION (CNS) AS WELL. 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(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE. ATTEMPT #1 04/10/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE ALL THE ADDITIONAL DEVICE INFORMATION AS REQUESTED. CENTRAL NURSE'S STATION: MODEL: NI, SN: NI, DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: NI, RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER(S): MODEL: ZM-521PA, SN: NI, DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER(S): MODEL: ZM-531PA, SN: NI, DEVICE MANUFACTURER DATE: NI, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NOT RETURNED.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS AN ERROR LIGHT. THEY HAVE TRIED REBOOTING THE UNIT, AND IT STILL COMES UP WITH AN ERROR. THEY WOULD LIKE TO SEND THE DEVICE IN FOR REPAIR TO CLEAR THE ERROR. THEY WERE GETTING COMMUNICATION LOSS ERRORS ON THE CENTRAL NURSE'S STATION (CNS) AS WELL. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF THE COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS AN ERROR LIGHT. THEY HAVE TRIED REBOOTING THE UNIT, AND IT STILL COMES UP WITH AN ERROR. THEY WOULD LIKE TO SEND THE DEVICE IN FOR REPAIR TO CLEAR THE ERROR. THEY WERE GETTING COMMUNICATION LOSS ERRORS ON THE CENTRAL NURSE'S STATION (CNS) AS WELL. NO PATIENT HARM WAS REPORTED. INVESTIGATION CONCLUSION: THE COMPLAINT DEVICE WAS RECEIVED. THE UNIT WAS EVALUATED AND THE COMPLAINT WAS DUPLICATED. THE CAUSE WAS DETERMINED TO BE SOFTWARE CORRUPTION. THE FOLLOWING FIELD(S) CONTAINS NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED. D10 CONCOMITANT MEDICAL DEVICE. ATTEMPT #1 04/10/2025 EMAILED CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL ITEMS UNDER THE NO INFORMATION SECTION. THE CUSTOMER RESPONDED BACK WITH COMPLAINT DETAILS, BUT THEY DID NOT PROVIDE ALL THE ADDITIONAL DEVICE INFORMATION AS REQUESTED. CENTRAL NURSE'S STATION. MODEL: NI. SN: NI. DEVICE MANUFACTURER DATE: NI. UNIQUE IDENTIFIER (UDI) #: NI. RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER(S) MODEL: ZM-521PA.. SN: NI DEVICE MANUFACTURER DATE: NI . UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED. TELEMETRY TRANSMITTER(S) MODEL: ZM-531PA. SN: NI. DEVICE MANUFACTURER DATE: NI . UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NOT RETURNED. 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) HAS AN ERROR LIGHT. THEY HAVE TRIED REBOOTING THE UNIT, AND IT STILL COMES UP WITH AN ERROR. THEY WOULD LIKE TO SEND THE DEVICE IN FOR REPAIR TO CLEAR THE ERROR. THEY WERE GETTING COMMUNICATION LOSS ERRORS ON THE CENTRAL NURSE'S STATION (CNS) AS WELL. NO PATIENT HARM WAS REPORTED.