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

Model Number	BSM-3552
Medical Device Problem Codes	Power Problem (3010); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (biomed) reported that this was one of 3 life scope monitors that shut down while in patient use and then gave a "device error" message when they booted back up.All 3 devices dropped out at the same time.The other 2 devices were reported in tickets 300433550 and 300433765.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (biomed) reported that this was one of 3 life scope monitors that shut down while in patient use and then gave a "device error" message when they booted back up.All 3 devices dropped out at the same time.The other 2 devices were reported in tickets 300433550 and 300433765.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: 05/14/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.Attempt # 2: 05/18/2026 emailed the customer via microsoft outlook for the information in the ni list above: no reply was received.

• Brand Name: Life Scope VS
• 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 Tomioka 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: 25206265
• Report Number: 8030229-2026-06629
• Device Sequence Number: 21353065
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: (01)04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K201949
• 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): 08/28/2026

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-3552
• Device Catalogue Number: BSM-3552A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2020
• 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