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

Model Number	BSM-1753
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) intermittently failed to inflate for non-invasive blood pressure (nibp) measurements.The issue occurred multiple times without displaying any error messages, even after replacing the cuff and hose.The bme removed the battery and rebooted the bsm, which temporarily resolved the problem; however, the nibp issue eventually returns.No patient harm was reported.Investigation summary: the evaluation shows that the reported issue was duplicated, and the root cause of the reported issue is due to cracked red pin and pump failure.No further investigation will be performed.Trending will continue to be monitored for this device, incidents, issues, and causes.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: bsm: model #: mu-631ra, serial #: (b)(6), device manufacturer data: 06/05/2018 (june), unique identifier (udi) #: (b)(4), returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) intermittently failed to inflate for non-invasive blood pressure (nibp) measurements.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: 23923551
• Report Number: 8030229-2025-05937
• Device Sequence Number: 15710887
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: (01)04931921111871
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/30/2025

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: 12/18/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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: BSM
• Patient Sex: Unknown