MAUDE Adverse Event Report: Nihon Kohden Corporation Life Scope TR; Bedside Monitor

Model Number	MU-651RA
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the left side of the bedside monitor (bsm) screen was blank and did not display numerical values.The issue occurred during a surgical case, and the surgeon was unable to reboot the bsm; however, the procedure was completed successfully.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the left side of the bedside monitor (bsm) screen was blank and did not display numerical values.The issue occurred during a surgical case, and the surgeon was unable to reboot the bsm; however, the procedure was completed successfully.No patient harm was reported.The bme noted that when the menu button was pressed, the numerical data briefly reappeared for 1-3 seconds.They also observed that the non-invasive blood pressure (nibp) numerical data intermittently blinked in and out.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 contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 06/02/2026 emailed the bme for the information in the ni list above and the bsm model and serial number: no reply was received.Attempt # 2: 06/03/2026 emailed the bme for the information in the ni list above and the bsm model and serial number: no reply was received.Attempt # 3: 06/15/2026 emailed the bme for the information in the ni list above and the bsm model and serial number: the bme provided the bsm model and serial number.The bme replied that they could not figure out the root cause.Troubleshooting steps they followed was to reboot the bsm post procedure and no issues have arisen since.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: input unit / transport monitor model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.

• 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: 25608520
• Report Number: 8030229-2026-06693
• Device Sequence Number: 5533606
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/03/2026

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-651RA
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2013
• 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: INPUT UNIT / TRANSPORT MONITOR
• Patient Sex: Unknown