ORG-9110A

Description of Event or Problem

BIOMEDICAL ENGINEER (BME) REPORTED HAVING AN ISSUE WHERE THE TELEMETRY DEVICES THAT WERE BEING MONITORED BY THIS (ORG) MULTIPLE PATIENT RECEIVER AND CENTRAL NURSE STATION (CNS) WERE GETTING A LOT OF NOISE, ARTIFACT AND THE ECG SIGNAL WAS DROPPING OUT. NO HARM TO ANY PATIENTS REPORTED. NIHON KOHDEN TECHNICIAN DID TROUBLESHOOTING WITH THE BME AND FOUND THAT THIS IS A SIGNAL LOSS ISSUE BETWEEN DEVICES AT THE TIME THIS WAS OCCURRING. NK TECHNICAL SUPPORT HAD THE BME LOOK AT THE ANTENNA IN ROOM 253, THE INDICATOR LIGHT WAS SOLID GREEN WITH NO INTERMITTENT DIMMING. BME WENT TO THE RNS (REMOTE NURSE STATION) TO SEE WHICH ORG WAS MONITORING THIS UNIT AND FOUND IT WAS THE ORG-9110A SERNO 1174 WHICH ENDED UP BEING THE DEVICE WITH THE SIGNAL LOSS ISSUE. BME REPORTED THAT THEY HAVE MANY SPARE ORG DEVICES, SO THEY REMOVED THIS ORG FROM SERVICE AND ADDED ANOTHER ONE WITH THE APPROPRIATE BED ID'S AND CHANNELS, VERIFIED THAT THEY WERE RECEIVING ALL CHANNELS, AND THEY DID NOT SEE ANY INTERFERENCE. THE BME REPORTED THAT SINCE THIS ORG IS OUT OF WARRANTY, IT IS UNLIKELY THAT THEY ARE GOING TO SEND IT INTO NK FOR SERVICE.

Additional Manufacturer Narrative

BIOMEDICAL ENGINEER (BME) REPORTED HAVING AN ISSUE WHERE THE TELEMETRY DEVICES THAT WERE BEING MONITORED BY THIS (ORG) MULTIPLE PATIENT RECEIVER AND CENTRAL NURSE STATION (CNS) WERE GETTING A LOT OF NOISE, ARTIFACT AND THE ECG SIGNAL WAS DROPPING OUT. NO HARM TO ANY PATIENTS REPORTED. NIHON KOHDEN TECHNICIAN DID TROUBLESHOOTING WITH THE BME AND FOUND THAT THIS IS A SIGNAL LOSS ISSUE BETWEEN DEVICES AT THE TIME THIS WAS OCCURRING. NK TECHNICAL SUPPORT HAD THE BME LOOK AT THE ANTENNA IN ROOM 253, THE INDICATOR LIGHT WAS SOLID GREEN WITH NO INTERMITTENT DIMMING. BME WENT TO THE RNS (REMOTE NURSE STATION) TO SEE WHICH ORG WAS MONITORING THIS UNIT AND FOUND IT WAS THE ORG-9110A SERNO 1174 WHICH ENDED UP BEING THE DEVICE WITH THE SIGNAL LOSS ISSUE. BME REPORTED THAT THEY HAVE MANY SPARE ORG DEVICES, SO THEY REMOVED THIS ORG FROM SERVICE AND ADDED ANOTHER ONE WITH THE APPROPRIATE BED ID'S AND CHANNELS, VERIFIED THAT THEY WERE RECEIVING ALL CHANNELS, AND THEY DID NOT SEE ANY INTERFERENCE. THE BME REPORTED THAT SINCE THIS ORG IS OUT OF WARRANTY, IT IS UNLIKELY THAT THEY ARE GOING TO SEND IT INTO NK FOR SERVICE. 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. ATTEMPT # 1: 02/23/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 03/06/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 03/07/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: REPLY WAS RECEIVED FROM THE BIOMEDICAL ENGINEER WHO PROVIDED THE PATIENTS GENDER, RACE, ETHNICITY AND THE CONCOMITANT MEDICAL DEVICES USED WITH THE ORG. WEIGHT UNKNOWN, DATE OF BIRTH: UNKNOWN, RELEVANT TEST/LABORATORY DATA, UNKNOWN. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: UNKNOWN. D10: CONCOMITANT MEDICAL DEVICES: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE ORG: MODEL #: PU-681RA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 08/22/2022. UNIQUE DEVICE IDENTIFIER(UDI): (B)(4). RETURNED TO NIHON KOHDEN: NO. MODEL: NGNK6803. SERIAL NUMBER: (B)(6). DEVICE MANUFACTURER DATA: 3/08/2023. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). RETURNED TO NIHON KOHDEN: NO. MODEL # : ZM-531PA. SERIAL # : (B)(6). DEVICE MANUFACTURER DATA: 04/01/2015. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). RETURNED TO NIHON KOHDEN: NO. MODEL # : ZM-531PA. SERIAL # : (B)(6). DEVICE MANUFACTURER DATA: 01/15/2021. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). RETURNED TO NIHON KOHDEN: NO.

Description of Event or Problem

BIOMEDICAL ENGINEER (BME) REPORTED HAVING AN ISSUE WHERE THE TELEMETRY DEVICES THAT WERE BEING MONITORED BY THIS (ORG) MULTIPLE PATIENT RECEIVER AND CENTRAL NURSE STATION (CNS) WERE GETTING A LOT OF NOISE, ARTIFACT AND THE ECG SIGNAL WAS DROPPING OUT. NO HARM TO ANY PATIENTS REPORTED. NIHON KOHDEN TECHNICIAN DID TROUBLESHOOTING WITH THE BME AND FOUND THAT THIS IS A SIGNAL LOSS ISSUE BETWEEN DEVICES AT THE TIME THIS WAS OCCURRING. NK TECHNICAL SUPPORT HAD THE BME LOOK AT THE ANTENNA IN ROOM 253, THE INDICATOR LIGHT WAS SOLID GREEN WITH NO INTERMITTENT DIMMING. BME WENT TO THE RNS (REMOTE NURSE STATION) TO SEE WHICH ORG WAS MONITORING THIS UNIT AND FOUND IT WAS THE ORG-9110A SERNO 1174 WHICH ENDED UP BEING THE DEVICE WITH THE SIGNAL LOSS ISSUE. BME REPORTED THAT THEY HAVE MANY SPARE ORG DEVICES, SO THEY REMOVED THIS ORG FROM SERVICE AND ADDED ANOTHER ONE WITH THE APPROPRIATE BED ID'S AND CHANNELS, VERIFIED THAT THEY WERE RECEIVING ALL CHANNELS, AND THEY DID NOT SEE ANY INTERFERENCE. THE BME REPORTED THAT SINCE THIS ORG IS OUT OF WARRANTY, IT IS UNLIKELY THAT THEY ARE GOING TO SEND IT INTO NK FOR SERVICE.

Additional Manufacturer Narrative

INCIDENT SUMMARY: ON 2/13/2024, THE CUSTOMER'S BIOMEDICAL ENGINEER (BME) REPORTED WAVEFORMS WERE DISAPPEARING FROM THE SYSTEM. THE CUSTOMER ALSO EXPERIENCED SIGNAL LOSS AND NOISE ARTIFACT/ECG (ELECTROCARDIOGRAM) ISSUES WITH THE TELEMETRY DEVICES (TELES), BEING MONITORED WITH THE CENTRAL NURSE'S STATION (CNS) DEVICE, USING THE NEXT GENERATION,NET KONNECT' (NGNK) DEVICE. THE ECG (ELECTROCARDIOGRAM) SIGNALS WERE INTERMITTENTLY DROPPING OUT FROM ALL THE TELE PACKS ON THE CNS, AND ORG TELE MONITORS. ADDITIONALLY, THE ZM TELE EXHIBITED SIGNIFICANT NOISE AND ARTIFACT, OVERWHELMING THE ECG SIGNAL, AND IMPACTING ROOMS 253, 254, AND 258. THE ISSUES WERE IDENTIFIED DURING PATIENT USE; HOWEVER, NO INJURIES, HARM, OR ADVERSE EVENTS WERE REPORTED. TROUBLESHOOTING MEASURES/RESULTS: TROUBLESHOOTING BY OUR NIHON KOHDEN (NK) TECHNICAL SUPPORT (TS) TECHNICIAN CONCLUDED THAT THE DEVICE, (ORG, SERIAL NUMBER: (B)(6)), WAS THE SOURCE OF THE ISSUES, AND IT WAS SCHEDULED FOR REPLACEMENT WITH A SPARE ORG DEVICE, BY THE FACILITY. SINCE THE FACILITY HAS SO MANY SPARE ORG DEVICES, THE DEVICE WILL NOT BE RETURNED TO US, AS THE WARRANTY HAD EXPIRED. INVESTIGATION SUMMARY: AFTER FOLLOWING UP WITH THE CUSTOMER, WE CONFIRMED THE ORG DEVICE WAS REPLACED AT THE FACILITY, TO RESOLVE THE ISSUE, AND NO ISSUES HAVE BEEN REPORTED SINCE. ROOT CAUSE ANALYSIS/RESULTS: BASED ON THE AVAILABLE INFORMATION, THE ISSUE WAS CAUSED BY THE ORG DEVICE, (ORG-9110A, SERIAL NUMBER: (B)(6)). THE DEVICE'S AGE SUGGESTS THAT THE REPORTED PROBLEMS ARE DUE TO WEAR AND TEAR, AS WELL AS THE NATURAL AGING AND DEGRADATION OF THE DEVICE AND ITS COMPONENTS, OVER TIME. THE DEVICE WAS INSTALLED AT THE FACILITY ON (B)(6) 2015, AND ITS WARRANTY EXPIRED ON OCTOBER 27, 2020. THIS INDICATES THAT THE DEVICE IS APPROXIMATELY 9 (NINE) YEARS AND 5 (FIVE) MONTHS OLD. SINCE THE WARRANTY HAS EXPIRED AND THE CUSTOMER DECIDED TO REPLACE THE ORG TELE AT THEIR FACILITY, (WITH A SPARE UNIT AT THE FACILITY), THE ORIGINAL DEVICE WILL NOT BE RETURNED. A REVIEW OF HISTORICAL DATA DOES NOT REVEAL A SIGNIFICANT TREND THAT WOULD CONTRIBUTE TO COMPONENT FAILURE THAT IS RELATED TO THE DESIGN OR MANUFACTURING OF THE DEVICE. ANY ISSUES DUE TO PRODUCT DEFICIENCIES, CAPTURED IN THE COMPLAINT HISTORY REVIEW, CAN BE ADDRESSED/RESOLVED BY TRANSITIONING TO ANOTHER DEVICE ATTEMPT # 1: 02/23/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 03/06/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 03/07/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: REPLY WAS RECEIVED FROM THE BIOMEDICAL ENGINEER WHO PROVIDED THE PATIENTS GENDER, RACE, ETHNICITY AND THE CONCOMITANT MEDICAL DEVICES USED WITH THE ORG. WEIGHT UNKNOWN, DATE OF BIRTH: UNKNOWN, RELEVANT TEST/LABORATORY DATA, UNKNOWN. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: UNKNOWN. D10: CONCOMITANT MEDICAL DEVICES: THE FOLLOWING DEVICE(S) WERE USED IN CONJUNCTION WITH THE ORG: MODEL #: PU-681RA. SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 08/22/2022, UNIQUE DEVICE IDENTIFIER(UDI): (B)(4), RETURNED TO NIHON KOHDEN: NO. MODEL: NGNK6803. SERIAL NUMBER: (B)(6). DEVICE MANUFACTURER DATA: 3/08/2023. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). RETURNED TO NIHON KOHDEN: NO. MODEL # : ZM-531PA. SERIAL # : (B)(6). DEVICE MANUFACTURER DATA: 04/01/2015. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). RETURNED TO NIHON KOHDEN: NO. MODEL # : ZM-531PA. SERIAL # : (B)(6). DEVICE MANUFACTURER DATA: 01/15/2021. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). RETURNED TO NIHON KOHDEN: NO. 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 CODES. H10: ADDITIONAL MANUFACTURER NARRATIVE.