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

Model Number	BSM-3532
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) was experiencing waveform dropouts again.A previous instance of this issue was reported in ticket (b)(4).The cause of the dropouts in that ticket was found to be interference or a faulty lead set.Technical support (ts) suggested the bme test the device with a simulator and burn it in for 24 hours to check for dropouts.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) reported that the bedside monitor (bsm) was experiencing waveform dropouts.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) was experiencing waveform dropouts.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) was experiencing waveform dropouts again.A previous instance of this issue was reported in ticket (b)(4).The cause of the dropouts in that ticket was found to be interference or a faulty lead set.No patient harm was reported.Investigation summary: technical support (ts) suggested that the bme test the device with a simulator and burn it in for 24 hours to check for waveform dropouts.The device was tested with an ecg simulator for 48 hours and no issues were observed.Based on the customer's evaluation, the reported issue could not be duplicated.Therefore, the root cause of the reported issue could not be determined.Nk will continue to monitor and trend.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 10/06/2025 emailed the customer via microsoft outlook for the information in the ni list above: the customer replied, but did not provide the requested information.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 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: 23383291
• Report Number: 8030229-2025-05707
• Device Sequence Number: 11977770
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: (01)04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 12/09/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• 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