ORG-9100A

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6). NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6). 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 CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 04/28/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 05/12/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 05/16/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: THE BME REPLIED WITH THE CNS INFORMATION BUT DID NOT HAVE THE TRANSMITTERS' INFORMATION. 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: 02/15/2021 (FEB. 15, 2021) UNIQUE IDENTIFIER (UDI) #: (B)(4). ZM TRANSMITTERS: MODEL #:NI SERIAL #: NI DEVICE MANUFACTURER DATA: NI UNIQUE IDENTIFIER (UDI) #: NI.

Description of Event or Problem

THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6)) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6)). NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6)) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6)). NO PATIENT HARM WAS REPORTED. INVESTIGATION SUMMARY: SPORADIC ECG READINGS (FLUCTUATING BETWEEN 90-120 BPM) ON TELE 8, DESPITE STABLE READINGS ON THE SIMULATOR. NK TECH SUPPORT ADVISED TESTING A DIFFERENT TELEMETRY UNIT WITH THE SAME RECEIVER, WHICH CONFIRMED THE ISSUE WAS WITH THE RECEIVER. THE BIOMED REPLACED THE RECEIVER CARD IN THE ORG, RESOLVING THE PROBLEM. THE CNS INVOLVED WAS A PU-681RA (SN: (B)(6)). THE ISSUE RESOLVED WHEN THE CUSTOMER REPLACED THE RECEIVER CARDS IN THE ORG. ROOT CAUSE DETERMINED TO BE COMPONENT FAILURE OF THE ORG RECEIVER CARD DUE TO AGING. THE DEVICE WAS INSTALLED ON (B)(6) 2008. THE ROOT CAUSE IS LIKELY RELATED TO DEVICE AGING. THE FOLLOWING FIELD CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN THE INFORMATION WERE MADE, BUT NOT PROVIDED: D10 04/28/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 05/12/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 05/16/2025 EMAILED THE BME FOR ALL INFORMATION IN THE NI LIST ABOVE: THE BME REPLIED WITH THE CNS INFORMATION BUT DID NOT HAVE THE TRANSMITTERS' INFORMATION. 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: 02/15/2021 (FEB. 15, 2021). UNIQUE IDENTIFIER (UDI) #: (B)(4). ZM TRANSMITTERS: MODEL #:NI. SERIAL #: NI. DEVICE MANUFACTURER DATA: NI. UNIQUE IDENTIFIER (UDI) #: NI. 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.