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

Model Number	BSM-3532
Medical Device Problem Codes	Device Alarm System (1012); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Death
Event or Problem Description
The biomedical engineer (bme) reported a patient event involving a death while the patient was connected to the bedside monitor (bsm).The bme requested a review of the device logs to determine whether the monitor alarmed appropriately and whether a staff member silenced the alarm.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported a patient event involving a death while the patient was connected to the bedside monitor (bsm).The bme requested a review of the device logs to determine whether the monitor alarmed appropriately and whether a staff member silenced the alarm.The event occurred on (b)(6) 2026 from 7:36 a.M.To 7:48 a.M.Logs were obtained from the bsm and the central nurse station (cns; pu-681ra, sn: (b)(6)).An nk clinical application specialist (cas) reviewed the logs and spoke with the bme and risk manager.The review confirmed that the monitor alarmed appropriately.The bme and risk manager discovered that a provider at the cns had silenced the crisis alarms; as a result, the nurses were unaware that the patient was coding.The customer acknowledged that the event involved user error.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: d10 concomitant medical device: the following device was used in conjunction with the bsm: cns: model #: pu-681ra serial #: (b)(6) device manufacturer data: 08/01/2019 (aug) unique identifier (udi) #: (b)(4) returned to nihon kohden: na.

• 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: 50897036
• Report Number: 8030229-2026-07179
• Device Sequence Number: 6026507
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: (01)04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BSM-3532
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2019
• 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: CNS
• Outcome Attributed to Adverse Event: Death
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 169 LB
• Patient Race: White