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

Model Number	BSM-1753
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the bsm displayed a lot of noise (artifacts) on the ecg and resp waveforms.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bsm displayed a lot of noise (artifacts) on the ecg and resp waveforms.They tested with other lead sets and on a simulator with no change.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: d10 concomitant medical device: the following devices were used in conjunction with the bsm: g5 monitor: model #: cu-151r / csm-1501.Serial #: (b)(6).Device manufacturer data: 07/25/2024 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Central nurse's station: model #: cns-2101a.Serial #: (b)(6).Device manufacturer data: 01/29/2024.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bsm displayed a lot of noise (artifacts) on the ecg and resp (respiration) waveforms.They tested with other lead sets and on a simulator with no change.No patient harm was reported.Investigation summary: the complaint device was returned to nk for evaluation and exchange.During the evaluation, no visible physical damage, scratches, or signs of liquid exposure were observed.All major functions, including nibp, spo2, ecg, and multi-socket connections were tested.The reported issue was successfully duplicated, confirming that the ecg module was defective.The ecg module requires replacement.The evaluation showed that the root cause of the reported issue was due to an ecg module failure.Nk will continue to monitor and trend.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the bsm: g5 monitor: model #: cu-151r / csm-1501.Serial #: (b)(6).Device manufacturer data: 07/25/2024.Unique identifier (udi) #:(b)(4).Returned to nihon kohden: na.Central nurse's station: model #: cns-2101a.Serial #: (b)(6).Device manufacturer data: 01/29/2024.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Additional information: b4 date of this report.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.
Event or Problem Description
The biomedical engineer (bme) reported that the bsm displayed a lot of noise (artifacts) on the ecg and resp waveforms.No patient harm was reported.

• Brand Name: LIFE SCOPE PT
• 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 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: 23466618
• Report Number: 8030229-2025-05764
• Device Sequence Number: 15935607
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: (01)04931921111871
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K220976
• 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): 12/12/2025

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: BSM-1753
• Device Catalogue Number: BSM-1753A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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: CENTRAL NURSE'S STATION (CNS-2101A); CENTRAL NURSE'S STATION (CNS-2101A); G5 MONITOR (CU-151R / CSM-1501); G5 MONITOR (CU-151R / CSM-1501)
• Patient Sex: Unknown