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

Model Number	BSM-1733
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005); Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (biomed) reported that while in patient use, the bsm-1733a was working but then for some reason, it stopped reading vitals.The bsm would then not power back on.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (biomed) reported that while in patient use, the bsm-1733a was working but then for some reason, it stopped reading vitals.The bsm would then not power back on.He replaced the battery with a fully charged one and left it on a charging dock, but the device would not power on.When pressing and holding the power button, the qi pack on top of the bsm, as well as its power and link light would turn on but the bsm would not.No patient harm was reported.Investigation summary: the complaint device was returned to nk for evaluation and repair.During the evaluation, the reported issue could not be duplicated.As such, the complaint could not be confirmed, and a root cause could not be determined.Nk will continue to monitor and trend.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.

• 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: 25840484
• Report Number: 8030229-2026-06853
• Device Sequence Number: 13107454
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 08/10/2026

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-1733
• Device Catalogue Number: BSM-1733A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2026
• 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: 06/23/2026
• Supplement Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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