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

Model Number	BSM-1753
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the ecgs show a lot of artifacts.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that the ecgs show a lot of artifacts.The customer changed out the unit when they noticed the issue.According to the customer, they changed out the electrodes, leads and cable; however, the issue remained.The original leads and cable are working on the replacement unit without issue.There was no patient injury 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(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 12/08/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 2: 12/10/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: 12/12/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the ecgs show a lot of artifacts.The customer changed out the unit when they noticed the issue.According to the customer, they changed out the electrodes, leads and cable; however, the issue remained.The original leads and cable are working on the replacement unit without issue.There was no patient injury reported.Investigation summary: the device with the reported issue was returned for evaluation.During the evaluation, the reported issue could not be duplicated.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 12/08/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 2: 12/10/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: 12/12/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.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 that the ecgs show a lot of artifacts.There was no patient injury 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: 23804283
• Report Number: 8030229-2025-05899
• Device Sequence Number: 7686135
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: (01)04931921111871
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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-1753
• Device Catalogue Number: BSM-1753A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• 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