MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM

Model Number	CU-172R
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the a-line value spiked, they were unable to clear it, and the values would not read correctly following the spike.It is unclear how it was incorrect or how it was determined to be incorrect.The nurse removed and reinserted the bp cable and the issue resolved.The customer was unable to duplicate the issue with a simulator, and they have had no issues since.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: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device attempt #1 02/24/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 02/26/2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 03/02/2026 emailed customer via microsoft outlook for all items under the no information section.No reply was received.
Event or Problem Description
The biomedical engineer (bme) reported that the a-line value spiked, they were unable to clear it, and the values would not read correctly following the spike.It is unclear how it was incorrect or how it was determined to be incorrect.The nurse removed and reinserted the bp cable and the issue resolved.The customer was unable to duplicate the issue with a simulator, and they have had no issues since.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the a-line value spiked, they were unable to clear it, and the values would not read correctly following the spike.It is unclear how it was incorrect or how it was determined to be incorrect.The nurse removed and reinserted the bp cable and the issue resolved.The customer was unable to duplicate the issue with a simulator, and they have had no issues since.No patient harm was reported.Investigation summary: we were unable to confirm the reported issue.It is unclear if the values were incorrect and/or how it was determined that the values were incorrect.Reportedly the bp (blood pressure) cable was removed and reinserted to resolve the issue.The issue was not duplicated with the issue with a simulator, and no issues related to this issue have been reported since.Nkc (nihon kohden corporate) also investigated the issue further and the results are noted below.Nkc log review results: nkc focused the review on the bedside monitor logs around the reported occurrence times of (b)(6) 2026, from approximately 18:35 to 18:45, and around 19:36.As a result of the review, no device errors or abnormal behavior were identified in the bedside monitor logs.Therefore, it is considered that the bedside monitor itself was operating normally during the reported period.·around 18:35 - 18:45 the log data shows that art high limit alarms occurred, along with intermittent occurrences of the following technical alarms: art out_of_range art zero_out_of_range the value recorded for the art high limit alarm was "300." additionally, art out_of_range continued to occur intermittently until around 19:00.· the following events were also recorded in the logs: 19:00 - art connector_off occurred 19:05 - art connector_off ended based on this information, it is believed that the art connector was disconnected and reconnected for the first time at this timing.However, the logs indicate that even after the connector reconnection, the following conditions continued: art out_of_range art zero_unstable as a result, the logs show that the art connector was repeatedly disconnected and reconnected (art connector_off events) as part of the troubleshooting process.· during this period, the art high limit alarm value "300" was also recorded multiple times.2) around 19:36 according to the log data, art out_of_range occurred during the following period: 19:33:34 - 19:36:25 during this time, the art high limit alarm value recorded was "300." discussion based on the log analysis, the bedside monitor appears to have been operating normally.· according to the device specifications, the maximum displayable value is limited to 300.If the measured value exceeds this limit, the monitor displays a fixed value of 300, and the out_of_range technical message is generated.· in addition, the following observations were made: zero_out_of_range technical alarms were recorded spike-like noise was observed in the art waveform no abnormal logs were detected on the monitor side conclusion: based on these findings, it is considered that the cause most likely originated from the patient-side measurement system connected through the input unit (e.G., the transducer system) rather than the monitor itself.· reference (user manual description) out_of_range measured value is outside the measurable range transducer malfunction zero_out_of_range transducer abnormality monitor malfunction zero_unstable not open to atmosphere during zero calibration pressure unstable during zero calibration.· since the bedside monitor is considered to have been operating normally, no specific corrective or preventive action has been identified.However, based on the content of the technical alarms that occurred, it is considered highly likely that the cause originated downstream of the input unit (i.E., on the patient side or within the transducer system).Resolution notes: the customer was provided with education on the matter, and we requested additional information to investigate the matter further.Despite our follow-up attempts (noted in the section above), the customer did not provide any further details.Since education was last provided no further issues related to this incident have been reported to date.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device attempt #1 (b)(6) 2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2025 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 2026 emailed customer via microsoft outlook for all items under the no information section.No reply was received.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.
Event or Problem Description
The biomedical engineer (bme) reported that the a-line value spiked, they were unable to clear it, and the values would not read correctly following the spike.It is unclear how it was incorrect or how it was determined to be incorrect.The nurse removed and reinserted the bp cable and the issue resolved.The customer was unable to duplicate the issue with a simulator, and they have had no issues since.No patient harm was reported.

• Brand Name: NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM
• Common Device Name: BEDSIDE MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 24565396
• Report Number: 8030229-2026-06299
• Device Sequence Number: 12858238
• Product Code: MHX
• UDI-Device Identifier: 04931921004517
• UDI-Public: (01)04931921004517
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CU-172R
• Device Catalogue Number: CU-172R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown