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

Model Number	BSM-1733
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor was not taking full nibp readings.The nibp was only pumping to 30-35 mmhg and no error messages were displayed.Today, however, the device is able to take proper readings without any issues.Currently, the device is functioning properly.He was wondering what may have caused the issue.Since they are unable to duplicate the problem, we cannot determine the root cause.Tech support (ts) advised him that it is possible there was a faulty hose or cuff, or that the connections were not secured properly at the time.At this time, he is unable to duplicate the issue.No patient harm was reported.Investigation conclusion: based on the available information, the customer was unable to duplicate the issue, and the device is functioning as expected.No further investigation will be performed.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor was not taking full nibp readings.The nibp was only pumping to 30-35 mmhg and no error messages were displayed.Today, however, the device is able to take proper readings without any issues.Currently, the device is functioning properly.He was wondering what may have caused the issue.Since they are unable to duplicate the problem, we cannot determine the root cause.Tech support (ts) advised him that it is possible there was a faulty hose or cuff, or that the connections were not secured properly at the time.At this time, he is unable to duplicate the issue.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: 24423640
• Report Number: 8030229-2026-06228
• Device Sequence Number: 5928710
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 02/23/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown