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

Model Number	BSM-3532
Medical Device Problem Codes	No Display/Image (1183); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) had a black screen with a solid blue alarm indicator light.The bsm was unresponsive to any input from both the touchscreen and the hard buttons.Technical support (ts) had the bme try to reboot the unit, but it was unresponsive to the power button.They unplugged it for 5 minutes, plugged it back in, and it behaved the same once powered on.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: 09/12/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 09/26/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: 10/08/2025 emailed the bme for all information in the ni list above: no reply was received.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) had a black screen with a solid blue alarm indicator light.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) had a black screen with a solid blue alarm indicator light.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) had a black screen with a solid blue alarm indicator light.The bsm was unresponsive to any input from both the touchscreen and the hard buttons.Technical support (ts) had the bme try to reboot the unit, but it was unresponsive to the power button.They unplugged it for 5 minutes, plugged it back in, and it behaved the same once powered on.No patient harm was reported.Investigation summary: the evaluation and functional testing of the returned device successfully duplicated the reported issue.The root cause of the reported issue is due to the failure of the main board.No further investigation will be performed.There was no patient involvement, no injury, no harm, nor any adverse event, due to the reported issue.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: 09/12/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 2: 09/26/2025 emailed the bme for all information in the ni list above: no reply was received.Attempt # 3: 10/08/2025 emailed the bme for all information in the ni list above: no reply was received.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 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: 23248194
• Report Number: 8030229-2025-05550
• Device Sequence Number: 10441646
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: (01)04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 10/21/2025

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-3532
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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: NI.; NI.
• Patient Sex: Unknown