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

Model Number	BSM-3552
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that their clinical staff witnessed this bedside monitor (bsm) had artifacts and showing ecg readings that were unstable, resulting in a tachycardia alarm.Biomed tested the bsm on a simulator but was unable to duplicate the complaint.No reports of patient harm.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 their clinical staff witnessed this bedside monitor (bsm) had artifacts and showing ecg readings that were unstable, resulting in a tachycardia alarm.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that their clinical staff witnessed this bedside monitor (bsm) had artifacts and showing ecg readings that were unstable, resulting in a tachycardia alarm.Biomed tested the bsm on a simulator but was unable to duplicate the complaint.No reports of patient harm.Investigation summary: based on the available information, the customer hooked up the unit on the simulator in the biomed shop - and the reported issue could not be duplicated.No further investigation will be performed.Although there was a patient involved, there were no reports of injury, no harm, nor any adverse events, due to the reported issue.Trending will continue to be monitored for this device, incidents, issues, and causes.Attempt #1: 12/04/2025 emailed the bme for additional information.No reply was received.Attempt #2; 12/12/2025 emailed the bme for additional information.No reply was received.Attempt #3: 12/16/2025 emailed the bme for additional information.No reply was received.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type?.H4 device manufacturer date.H6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that their clinical staff witnessed this bedside monitor (bsm) had artifacts and showing ecg readings that were unstable, resulting in a tachycardia alarm.No patient harm 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: 23828485
• Report Number: 8030229-2025-05974
• Device Sequence Number: 15769969
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: (01)04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/09/2026

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-3552
• Device Catalogue Number: BSM-3552A
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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
• Patient Sex: Unknown