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

Model Number	BSM-1733
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported receiving the error message "check input unit battery" on a main unit (cu-151) when they dock this bedside monitor (bsm-1733, sn: (b)(6) ).The bsm-1733 would not stay powered when it was undocked from the main unit despite using a new charged battery.They replaced the bsm-1733 with another one and they did not receive the error message.Not in patient use.Investigation summary: the evaluation of the returned device (bsm-1733, sn: (b)(6) ) shows that this complaint is confirmed.The root cause of the reported issue is due to power board failure.No further investigation will be performed.Trending will continue to be monitored for this device, incidents, issues, and causes.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 11/26/2025 emailed the bme for the remaining information in the ni list above: no reply was received.Attempt # 2: 11/26/2025 called the bme for the remaining information in the ni list above: the bme said they did not have the serial number of the cu-151r that the reported device was docked to.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: bsm: model #: cu-151r serial #: ni unique identifier (udi) #: (b)(4).
Event or Problem Description
The biomedical engineer (bme) reported receiving the error message "check input unit battery" on a main unit when they dock this bedside monitor (bsm-1733).The bsm-1733 would not stay powered when it was undocked from the main unit despite using a new charged battery.Not in patient use.

• 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: 23657595
• Report Number: 8030229-2025-05869
• Device Sequence Number: 10027376
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: (01)04931921111833
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 11/26/2025

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: 11/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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: BSM (CU-151)
• Patient Sex: Unknown