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

Model Number	BSM-3572
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	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the customer reported a noisy ecg on this unit.The issue was discovered during setup.The unit was not in patient use at the time.Investigation summary: evaluation of the returned device showed that the reported issue could not be duplicated.The unit was tested for 24 hours and it operated as per the manufacturer's specifications.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? h11 additional manufacturer narrative.
Event or Problem Description
The customer reported a noisy ecg on this unit.The unit was not in patient use at the time.
Event or Problem Description
The customer reported a noisy ecg on this unit.The unit was not in patient use at the time.
Additional Manufacturer Narrative
The customer reported a noisy ecg on this unit.The issue was discovered during setup.The unit was not in patient use at the time.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.

• 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: 23347881
• Report Number: 8030229-2025-05567
• Device Sequence Number: 9461241
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: (01)04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/19/2025

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-3572
• Device Catalogue Number: BSM-3572A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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