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); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the bsm-1733a would not detect ecg while in patient use.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bsm-1733a would not detect ecg while in patient use.They swapped out the ecg leads and trunk cable, but the issue persisted.They received a "check electrode" followed by an "auto lead change" error message but, after multiple requests for more information, nk was unable to confirm if the errors were immediately seen or displayed after the cable changes.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.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 12/22/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 12/28/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 01/05/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bsm-1733a would not detect ecg while in patient use.They swapped out the ecg leads and trunk cable, but the issue persisted.They received a "check electrode" followed by an "auto lead change" error message but, after multiple requests for more information, nk was unable to confirm if the errors were immediately seen or displayed after the cable changes.No patient harm was reported.Investigation summary: the complaint device was returned to nk for evaluation and repair.During the evaluation, the reported complaint was confirmed and duplicated.The root cause was determined to be the failure of the ecg board.Nk will continue to monitor and trend.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 12/22/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 12/28/2025 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 3: 01/05/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Additional information: b4 date of this report.D9 device available for evaluation? 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.
Event or Problem Description
The biomedical engineer (bme) reported that the bsm-1733a would not detect ecg while in patient use.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: 24048356
• Report Number: 8030229-2026-06076
• Device Sequence Number: 9745520
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/12/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2015
• 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