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

Model Number	BSM-1733
Medical Device Problem Codes	No Device Output (1435); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nibp pump will not initiate when selecting the nibp function on their bsm-1733a bedside monitor (bsm).The issue was identified during a case.Fortunately, the patient was also being monitored with an invasive blood pressure line, allowing an alternative reading to be obtained.The issue was brought to the biomed's attention via a work order.No patient harm was reported.The biomed tested the unit as a standalone device and was able to duplicate the issue in his shop.He stated he cannot hear the typical click or pump activation when initiating nibp.He swapped out the cuff and hose, and the issue persisted.When asked about cuff type, he confirmed they are using welch allyn cuffs but emphasized the cuff is not the issue, as the same cuff worked properly on another unit.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the nibp pump will not initiate when selecting the nibp function on their bsm-1733a bedside monitor (bsm).The issue was identified during a case.Fortunately, the patient was also being monitored with an invasive blood pressure line, allowing an alternative reading to be obtained.The issue was brought to the biomed's attention via a work order.No patient harm was reported.The biomed tested the unit as a standalone device and was able to duplicate the issue in his shop.He stated he cannot hear the typical click or pump activation when initiating nibp.He swapped out the cuff and hose, and the issue persisted.When asked about cuff type, he confirmed they are using welch allyn cuffs but emphasized the cuff is not the issue, as the same cuff worked properly on another unit.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.Additional device information: d10 concomitant medical device bedside monitor model: cu-172r.Sn: (b)(6).
Event or Problem Description
The customer reported that the nibp pump will not initiate when selecting the nibp function on their bsm-1733a bedside monitor (bsm).The issue was identified during a case.Fortunately, the patient was also being monitored with an invasive blood pressure line, allowing an alternative reading to be obtained.The issue was brought to the biomed's attention via a work order.No patient harm was reported.The biomed tested the unit as a standalone device and was able to duplicate the issue in his shop.He stated he cannot hear the typical click or pump activation when initiating nibp.He swapped out the cuff and hose, and the issue persisted.When asked about cuff type, he confirmed they are using welch allyn cuffs but emphasized the cuff is not the issue, as the same cuff worked properly on another unit.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that the nibp pump will not initiate when selecting the nibp function on their bsm-1733a bedside monitor (bsm).The issue was identified during a case.Fortunately, the patient was also being monitored with an invasive blood pressure line, allowing an alternative reading to be obtained.The issue was brought to the biomed's attention via a work order.No patient harm was reported.The biomed tested the unit as a standalone device and was able to duplicate the issue in his shop.He stated he cannot hear the typical click or pump activation when initiating nibp.He swapped out the cuff and hose, and the issue persisted.When asked about cuff type, he confirmed they are using welch allyn cuffs but emphasized the cuff is not the issue, as the same cuff worked properly on another unit.No patient harm was reported.Investigation conclusion: no device was returned for this complaint.Therefore, this complaint could not be confirmed, and the root cause of the reported issue could not be determined.No further investigation will be performed.Additional device information: d10 concomitant medical device bedside monitor.Model: cu-172r.Sn: (b)(6).Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? 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: 23824092
• Report Number: 8030229-2025-05959
• Device Sequence Number: 9294959
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/05/2026

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-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: 12/10/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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: CU-172R SN (B)(6); CU-172R SN (B)(6)
• Patient Sex: Unknown