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	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that excessive artifact / noise was detected on the bsm-1733a during setup by a nurse.There was no patient harm, and the patient was transferred to another bsm-1733a.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: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1 (b)(6) 2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device information as requested.
Event or Problem Description
The customer reported that excessive artifact / noise was detected on the bsm-1733a during setup by a nurse.There was no patient harm, and the patient was transferred to another bsm-1733a.No patient harm was reported.
Additional Manufacturer Narrative
The customer reported that excessive artifact / noise was detected on the bsm-1733a during setup by a nurse.There was no patient harm, and the patient was transferred to another bsm-1733a.No patient harm was reported.Investigation conclusion: the evaluation shows that this complaint is confirmed, and the root cause of the reported issue is due to physical damage and failure of internal components.No further investigation will be performed.Additional device information: the following field(s) contains no information (ni), as attempts to obtain information were made, but not provided.D10 concomitant medical device.Attempt #1: 10/30/2025 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device information as requested.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 customer reported that excessive artifact / noise was detected on the bsm-1733a during setup by a nurse.There was no patient harm, and the patient was transferred to another bsm-1733a.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: 23536267
• Report Number: 8030229-2025-05808
• Device Sequence Number: 18692669
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/07/2025

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-1733
• Device Catalogue Number: BSM-1733A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2018
• 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
• Patient Sex: Unknown