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

Model Number	BSM-3552
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the life scope monitor was idling on a standby screen when it started alarming and rebooting, showing a blue block memory error screen.Technical support (ts) tried troubleshooting with the bme, but when trying to load the software, it gave a "watchdog error" message before trying to reboot.It would then occasionally load the monitoring screen and alarm and then display the blue block memory errors again.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.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: remote network station (rns): model #: rns-6803-7480.Serial #: (b)(6).Device manufacturer data: 06/23/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the life scope monitor was idling on a standby screen when it started alarming and rebooting, showing a blue block memory error screen.Technical support (ts) tried troubleshooting with the bme, but when trying to load the software, it gave a "watchdog error" message before trying to reboot.It would then occasionally load the monitoring screen and alarm and then display the blue block memory errors again.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the life scope monitor was idling on a standby screen when it started alarming and rebooting, showing a blue block memory error screen.Technical support (ts) tried troubleshooting with the bme, but when trying to load the software, it gave a "watchdog error" message before trying to reboot.It would then occasionally load the monitoring screen and alarm and then display the blue block memory errors again.No patient harm was reported.Investigation summary: the complaint device was returned to nk for evaluation and exchange.During the evaluation, no visible physical damage, scratches, or signs of liquid exposure were observed.During testing, the reported issue of "spontaneous repeated reboots with errors" was successfully duplicated, confirming a failure of the main board, which requires replacement.The reported issue was duplicated, and the root cause of the reported issue is due to failure of the main board.Nk will continue to monitor and trend.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: remote network station (rns): model #: rns-6803-7480.Serial #: (b)(6).Device manufacturer data: 06/23/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Additional information: b4 date of this report.D10 concomitant medical device.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.
Event or Problem Description
The biomedical engineer (bme) reported that the life scope monitor was idling on a standby screen when it started alarming and rebooting, showing a blue block memory error screen.Technical support (ts) tried troubleshooting with the bme, but when trying to load the software, it gave a "watchdog error" message before trying to reboot.It would then occasionally load the monitoring screen and alarm and then display the blue block memory errors again.No patient harm was reported.

• 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: 23639740
• Report Number: 8030229-2025-05868
• Device Sequence Number: 15731303
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: (01)04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/12/2025

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-3552
• Device Catalogue Number: BSM-3552A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REMOTE NETWORK STATION (RNS-6803-7480, SN: (B)(6)
• Patient Sex: Unknown