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

Model Number	BSM-1753
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (biomed) reported that the bedside monitor (bsm-6000) was intermittently alarming and displaying a blue message across the screen during an endo case.This occurred while monitoring pulse ox.During troubleshooting they found that the issue followed the bsm-1753a.When rebooting both devices, the biomed undocked the bsm-1753a, which started alarming and displaying a "detected disk error format and restore disk" error message.When they tested the main bsm with a different bsm-1700, it was confirmed that no alarm or error displayed on the main bsm after a few minutes of operation.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.
Event or Problem Description
The biomedical engineer (biomed) reported that the bedside monitor (bsm-6000) was intermittently alarming and displaying a blue message across the screen during an endo case.This occurred while monitoring pulse ox.During troubleshooting they found that the issue followed the bsm-1753a.When rebooting both devices, the biomed undocked the bsm-1753a, which started alarming and displaying a "detected disk error format and restore disk" error message.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: 25095447
• Report Number: 8030229-2026-06585
• Device Sequence Number: 12031763
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: (01)04931921111871
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2015
• 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