MAUDE Adverse Event Report: Nihon Kohden Corporation Life Scope VS; Bedside Monitor

Model Number	BSM-3572
Medical Device Problem Codes	False Alarm (1013); Erratic or Intermittent Display (1182); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported intermittent ecg issues with the bedside monitor (bsm).No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported intermittent ecg issues with the bedside monitor (bsm).The main cable was replaced and initially appeared to resolve the issue.However, they received reports that the bsm alarmed ventricular fib when it was not present and did not display atrial fib that was shown on the ekg machine.The bsm did not have any error messages, and the issue occurred with multiple patients.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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 07/10/2026 emailed the bme for the information in the ni list above and for additional information: the bme replied that they were unable to obtain the cns information that was being used.They have not tested on a simulator yet due to other issues at work.They did not have a copy of the strips for nk to review, as they did not know the patient's name.Attempt # 2: 07/14/2026 emailed the bme regarding more information: no reply was received.Attempt # 3: 07/20/2026 emailed the bme regarding more information: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.

• 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: 50068737
• Report Number: 8030229-2026-06913
• Device Sequence Number: 10121203
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: (01)04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 07/29/2026

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-3572
• Device Catalogue Number: BSM-3572A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• 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