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

Model Number	MU-651RA
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) was called after hours and told they were experiencing st depression on all 8 patients, they were monitoring.They also told the bme that they rechecked the patients with a standalone ecg (mortara 380) and did not experience the st depression.The bme checked the monitors to see if they could pull up the history note but saw nothing.The bme did not have a patient simulator on hand to check units.The next day the ce tech who was on-site checked with the department, and the discrepancy was no longer there.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.
Event or Problem Description
The biomedical engineer (bme) was called after hours and told they were experiencing st depression on all 8 patients they were monitoring.They also told the bme that they rechecked the patients with a standalone ecg (mortara 380) and did not experience the st depression.The bme checked the monitors to see if they could pull up the history note but saw nothing.The bme did not have a patient simulator on hand to check units.The next day the ce tech who was on-site checked with the department, and the discrepancy was no longer there.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) was called after hours and told they were experiencing st depression on all 8 patients they were monitoring.They also told the bme that they rechecked the patients with a standalone ecg (mortara 380) and did not experience the st depression.The bme checked the monitors to see if they could pull up the history note but saw nothing.The bme did not have a patient simulator on hand to check units.The next day the ce tech who was on-site checked with the department, and the discrepancy was no longer there.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) was called after hours and told they were experiencing st depression on all 8 patients they were monitoring.They also told the bme that they rechecked the patients with a standalone ecg (mortara 380) and did not experience the st depression.The bme checked the monitors to see if they could pull up the history note but saw nothing.The bme did not have a patient simulator on hand to check units.The next day the ce tech who was on-site checked with the department, and the discrepancy was no longer there.No patient harm was reported.Investigation conclusion: the customer replied that the issue was resolved but they did not know how it was resolved.The complaint device would not be returned to nk.Root cause could not be determined.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: 23044682
• Report Number: 8030229-2025-05482
• Device Sequence Number: 10044134
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/18/2025

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-651RA
• Device Catalogue Number: MU-651RA
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2017
• 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