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

Model Number	BSM-1733
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported the bedside monitor (bsm) is intermittently giving inaccurate non-invasive blood pressure (nibp) readings, and the blood pressure pump sounds very weak.Customer indicated that multiple function tests were performed and the nibp pump is failing when compared to a known good unit.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported the bedside monitor (bsm) is intermittently giving inaccurate non-invasive blood pressure (nibp) readings, and the blood pressure pump sounds very weak.Customer indicated that multiple function tests were performed and the nibp pump is failing when compared to a known good unit.No patient harm was reported.Investigation summary: the reported issue was duplicated.Evaluation shows that the device failed the nibp check, and the root cause of the reported issue is due to nibp pump malfunction.No further investigation will be performed.Although there was a patient involved, there were no reports of injury, no harm, nor any adverse events, due to the reported issue.Trending will continue to be monitored for this device, incidents, issues, and causes.

• 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: 50867930
• Report Number: 8030229-2026-07150
• Device Sequence Number: 10673968
• 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
• Report Date (Section B): 09/23/2026

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: 09/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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