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

Model Number	BSM-1733
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse reported that the input unit showed ecg artifacts.They were using this unit with a g9 monitor and a docking station.No patient harm was reported.
Additional Manufacturer Narrative
The nurse reported that the input unit showed ecg artifacts.They were using this unit with a g9 monitor and a docking station.They tried changing the leads, electrodes, and electrode placement, but the issue persisted.The nurse planned to try swapping in another input unit next and call back with the results.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.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that the input unit showed ecg artifacts.They were using this unit with a g9 monitor and a docking station.They tried changing the leads, electrodes, and electrode placement, but the issue persisted.The nurse planned to try swapping in another input unit next and call back with the results.No patient harm was reported.Investigation summary: multiple attempts have been made to request additional information.However, no response was received.Therefore, this complaint could not be confirmed, and a 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: 10/08/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 10/14/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 10/22/2025 emailed the customer via microsoft outlook for the information in the ni list above: 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?.H3 device evaluated by manufacturer?.H6 event problem and evaluation codes.H11 additional manufacturer narrative.
Event or Problem Description
The nurse reported that the input unit showed ecg artifacts.They were using this unit with a g9 monitor and a docking station.No patient harm was reported.

• Brand Name: LIFE SCOPE PT
• 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 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: 23403247
• Report Number: 8030229-2025-05734
• Device Sequence Number: 21341870
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220976
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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-1733
• Device Catalogue Number: BSM-1733A
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2021
• 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