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

Model Number	MU-631RA
Medical Device Problem Codes	No Device Output (1435); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the bsm-6301a bedside monitor was not displaying the rhythm of the ecg.Another bsm-6301a bedside monitor was brought into the room to monitor the patient and to continue on the case.The bme stated that no matter what bsm-1700 they connect to the bsm-6301a bedside monitor, the issue follows the bsm-6301a bedside monitor.There were no error message when the ecg rhythm stopped displaying.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bsm-6301a bedside monitor was not displaying the rhythm of the ecg.Another bsm-6301a bedside monitor was brought into the room to monitor the patient and to continue on the case.The bme stated that no matter what bsm-1700 they connect to the bsm-6301a bedside monitor, the issue follows the bsm-6301a bedside monitor.There were no error message when the ecg rhythm stopped displaying.No patient harm was reported.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.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 series model: ni, sn: (b)(6), device manufacturer date: ni, unique identifier (udi) #: (b)(4), returned to nihon kohden: not returned.
Event or Problem Description
The biomedical engineer (bme) reported that the main bsm-6301a bedside monitor was not displaying the ecg rhythm.They tried to connect several bsm-1700s to this main bsm, and the issue would follow the main bsm.There were no error messages when the ecg rhythm stopped displaying.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the main bsm-6301a bedside monitor was not displaying the ecg rhythm.Another main bsm was brought into the room to monitor the patient and to continue the case.They tried to connect several bsm-1700s to this main bsm, and the issue would follow the main bsm.There were no error messages when the ecg rhythm stopped displaying.No patient harm was reported.Investigation summary: the reported device was returned for evaluation and repair.The unit was evaluated, and the complaint was duplicated.The cause of the issue was a circuit board failure.No further investigation will be performed.Trending will continue to be monitored for this device, incidents, issues, and causes.Bedside monitor bsm-1700 series: model: ni, sn: (b)(6), device manufacturer date: ni, unique identifier (udi) #: (b)(4), returned to nihon kohden: na.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: 21831433
• Report Number: 8030229-2025-04876
• Device Sequence Number: 19889604
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: (01)04931921103517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/17/2025

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-631RA
• Device Catalogue Number: MU-631RA
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BEDSIDE MONITOR BSM-1700 SERIES; BEDSIDE MONITOR BSM-1700 SERIES
• Patient Sex: Unknown