MAUDE Adverse Event Report: Nihon Kohden Corporation Life Scope PT; Bedside Monitor

Model Number	BSM-1733
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) would power off when it was undocked from a host/main bedside monitor.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) would power off when it was undocked from a host/main bedside monitor.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) would power off when it was undocked from a host/main bedside monitor.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: 08/06/2026 emailed the bme for the information in the ni list above: no reply was received.Attempt # 2: 08/13/2026 emailed the bme for the information in the ni list above: the bme replied they resolved the issue.Attempt # 3: 08/17/2026 emailed the bme how the issue was resolved and for the information in the ni list above: the bme replied that they thought replacing the battery resolved the issue, but it did not.Also, they did not know the host/bsm.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) would power off when it was undocked from a host/main bedside monitor.No patient harm was reported.Investigation summary: the reported issue was duplicated, and the root cause of the reported power issue was due to physical damage and failure of internal components.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: host/bsm model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: na.Additional information: b4 date of this report, 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.

• 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: 50477084
• Report Number: 8030229-2026-07053
• Device Sequence Number: 10234031
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/24/2026

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?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Host/BSM; Host/BSM
• Patient Sex: Unknown