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

Model Number	MU-671RA
Medical Device Problem Codes	Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) mu-671ra is flashing rapidly with lines appearing on the display.The issue was observed during patient use, in the middle of a case.They immediately brought in another monitor so the staff could continue, and patient vitals were monitored via the transport module during the downtime.They attempted to swap out the ecg leads and trunk cable to address the interference on the display, but this did not resolve the issue.He also replaced the transport module, but the display continued to flash rapidly.He also noted that the sawtooth waveform appears to be constant.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) mu-671ra is flashing rapidly with lines appearing on the display.The issue was observed during patient use, in the middle of a case.They immediately brought in another monitor so the staff could continue, and patient vitals were monitored via the transport module during the downtime.They attempted to swap out the ecg leads and trunk cable to address the interference on the display, but this did not resolve the issue.He also replaced the transport module, but the display continued to flash rapidly.He also noted that the sawtooth waveform appears to be constant.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 07/31/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the additional device information as requested.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) mu-671ra is flashing rapidly with lines appearing on the display.The issue was observed during patient use, in the middle of a case.They immediately brought in another monitor so the staff could continue, and patient vitals were monitored via the transport module during the downtime.They attempted to swap out the ecg leads and trunk cable to address the interference on the display, but this did not resolve the issue.He also replaced the transport module, but the display continued to flash rapidly.He also noted that the sawtooth waveform appears to be constant.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) mu-671ra is flashing rapidly with lines appearing on the display.The issue was observed during patient use, in the middle of a case.They immediately brought in another monitor so the staff could continue, and patient vitals were monitored via the transport module during the downtime.They attempted to swap out the ecg leads and trunk cable to address the interference on the display, but this did not resolve the issue.He also replaced the transport module, but the display continued to flash rapidly.He also noted that the sawtooth waveform appears to be constant.No patient harm was reported.Investigation conclusion: the complaint device was received.The unit was evaluated and the complaint could not be duplicated, however, the battery pack was found to be at 0% and after fully recharging, the unit operated normally.The operator's manual instructs the user to check that the battery is charged before use and before turning off the monitor.The cause was user error with battery maintenance.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 07/31/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back, but they did not provide the additional device information as requested.Additional information: b4 date of this report.D9 device available for evaluation.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type?.H3 device evaluated by manufacturer.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: 22734244
• Report Number: 8030229-2025-05265
• Device Sequence Number: 9104063
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: (01)04931921103562
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/10/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2018
• 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
• Patient Sex: Unknown