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

Model Number	BSM-3532
Medical Device Problem Codes	Signal Artifact/Noise (1036); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) had intermittent ecg interference.The issue occurred during in-patient use, and no patient harm was reported.They would always reboot the bsm; however, it would only resolve the issue temporarily.The bme swapped lead sets and the trunk cable, but the issue still showed random interference.Investigation summary: based on the evaluation of the returned device, this complaint could not be confirmed.The definitive root cause of the reported issue could not be determined.A known cause of ecg interference can be caused by electrical activity from nearby devices, poor electrode placement, or due to patient movement.Other causes of ecg failure have been identified as: fuzzy or inaccurate waveforms (e.G., sawtooth patterns) or wave artifacts (signal noise, lead placement, lead connection, network interference) are caused by faulty lead placement/faulty leads.Lead sets are used to acquire ecg readings, and the users should verify that the leads are authorized for use with the bsm in operation before monitoring a patient.Improper connection of leads (leads not properly seated), and/or damaged or contaminated leads (dirt, dust and/or cleaning residues) may contribute to ecg issues.If the leads are not seated properly to the bsm, readings will not appear properly.Users should ensure that all cable connections are secure before monitoring a patient.Damage to lead sets are most likely a result of mishandling that results in the damage to the inner wires of the leads.Damage to the conductive wires would prevent data from reaching the bsm and transferring over to the cns.Buildup of residues on contact points could interfere with the stable flow of data or create a weak signal that may appear as a flat line on the bsm or cns or as broken waveforms.Lead issues resulting in the above-mentioned failure modes would be immediately recognizable by the user and addressed promptly.These factors can also lead to missing numeric or numeric but no waveforms on a tile or missing expanded waveforms or waveforms that appear cut off.Trending will continue to be monitored for this device, incidents, issues, and causes.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: cns model #: cns-2101 serial #: (b)(6) device manufacturer data: 10/05/2023 (oct.5, 2023) unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) had intermittent ecg interference.No patient harm was reported.

• Brand Name: LIFE SCOPE VS
• 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: 21289273
• Report Number: 8030229-2025-04644
• Device Sequence Number: 7909360
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: (01)04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201949
• 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
• Report Date (Section B): 01/31/2025

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-3532
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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: CNS
• Patient Sex: Unknown