MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE TR; BEDSIDE MONITOR

Model Number	MU-671RA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) is displaying vitals on screen without issue.Intermittently, the wave for all parameters will reset and the wave will start over from the left side of the screen.At the central nurse's station (cns) the waves do not seem to have any issues.Also full disclosure at both the bsm and cns do not show any signs of this issue.They rebooted bsm-6000.They swapped lead and cables.Bsm-1700 attached to it as a stand alone did not seem to display this issue.They redocked the bsm-1700 into the bsm-6000.They did those troubleshooting steps but the issue persists, so tech support (ts) advised to swap the bsm-6000 out for the time being so additional troubleshooting could be done.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 10/31/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they were not sure what bsm-1700 was being used with the bsm-6000.Bedside monitor bsm-1700 model: ni.Sn: ni.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) is displaying vitals on screen without issue.Intermittently, the wave for all parameters will reset and the wave will start over from the left side of the screen.At the central nurse's station (cns) the waves do not seem to have any issues.Also full disclosure at both the bsm and cns do not show any signs of this issue.They rebooted bsm-6000.They swapped lead and cables.Bsm-1700 attached to it as a stand alone did not seem to display this issue.They redocked the bsm-1700 into the bsm-6000.They did those troubleshooting steps but the issue persists, so tech support (ts) advised to swap the bsm-6000 out for the time being so additional troubleshooting could be done.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) is displaying vitals on screen without issue.Intermittently, the wave for all parameters will reset and the wave will start over from the left side of the screen.At the central nurse's station (cns) the waves do not seem to have any issues.Also full disclosure at both the bsm and cns do not show any signs of this issue.They rebooted bsm-6000.They swapped lead and cables.Bsm-1700 attached to it as a stand alone did not seem to display this issue.They redocked the bsm-1700 into the bsm-6000.They did those troubleshooting steps but the issue persists, so tech support (ts) advised to swap the bsm-6000 out for the time being so additional troubleshooting could be done.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) is displaying vitals on screen without issue.Intermittently, the wave for all parameters will reset and the wave will start over from the left side of the screen.At the central nurse's station (cns) the waves do not seem to have any issues.Also full disclosure at both the bsm and cns do not show any signs of this issue.They rebooted bsm-6000.They swapped lead and cables.Bsm-1700 attached to it as a stand alone did not seem to display this issue.They redocked the bsm-1700 into the bsm-6000.They did those troubleshooting steps but the issue persists, so tech support (ts) advised to swap the bsm-6000 out for the time being so additional troubleshooting could be done.No patient harm was reported.Investigation conclusion: the customer replied that the issue was resolved.Specific resolution details were not provided.The complaint device would not be returned.The complaint could not be confirmed.Root cause could not be determined.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.Bedside monitor bsm-1700.Model: ni.Sn: 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.

• Brand Name: LIFE SCOPE TR
• 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: 23537668
• Report Number: 8030229-2025-05761
• Device Sequence Number: 9083589
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: (01)04931921103562
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• 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): 02/11/2026

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: MU-671RA
• Device Catalogue Number: MU-671RA
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2020
• 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: BEDSIDE MONITOR.; BEDSIDE MONITOR.
• Patient Sex: Unknown