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

Model Number	BSM-1753
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184); 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	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this bedside monitor (bsm) will not read ecg waveforms or bpm.According to the customer, they can see the imm-rr waveform and numeric; however, nothing for the heart rate.Technical support (ts) had the customer try known-good leads and cables and there was no change.Ts had the customer discharge and admit a fresh blank patient; however, the issue remained.There was no patient injury 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: 03/18/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 03/20/2026 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: 03/23/2026 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.
Event or Problem Description
The customer reported that this bedside monitor (bsm) will not read ecg waveforms or bpm.There was no patient injury 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: 24755851
• Report Number: 8030229-2026-06346
• Device Sequence Number: 12956812
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: (01)04931921111871
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/19/2026

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-1753
• Device Catalogue Number: BSM-1753A
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2017
• 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