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

Model Number	BSM-3572
Medical Device Problem Codes	Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the life scope monitor was in intermittent comm loss.This had been happening throughout the previous week.He stated that the device was on wlan and was on one end of the floor where there were no other wlan devices nearby.He tried swapping the qi wireless pack with a working unit, but the issue persisted.Technical support (ts) gave him some troubleshooting steps to try.He called back later to let ts know that he narrowed the issue down to the power connector for the wireless pack on the bsm.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: cns: model #: pu-621ra, serial #: (b)(6), device manufacturer data: 01/18/2016, 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 in intermittent comm loss.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the life scope monitor was in intermittent comm loss.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the life scope monitor was in intermittent comm loss.This had been happening throughout the previous week.He stated that the device was on wlan and was on one end of the floor where there were no other wlan devices nearby.He tried swapping the qi wireless pack with a working unit, but the issue persisted.Technical support (ts) gave him some troubleshooting steps to try.He called back later to let ts know that he narrowed the issue down to the power connector for the wireless pack on the bsm.No patient harm was reported.Investigation summary: the complaint device was returned to nk for evaluation and exchange.During the evaluation, there was no notable damage or evidence of fluid exposure present.During testing, the reported issue of intermittent communication loss could not be duplicated.The unit was tested in a wired state, as well as with a qi-420pa.Communication loss could not be induced by gently moving the qi power cable or lan cable.The unit passed all other basic functional tests.Per the evaluation of the device, this complaint was not confirmed.As such a root cause could not be determined.Nk will continue to monitor and trend.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: cns: model #: pu-621ra.Serial #: (b)(6).Device manufacturer data: 01/18/2016.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Additional information: b4 date of this report.D9 device available for evaluation?.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: 23498360
• Report Number: 8030229-2025-05782
• Device Sequence Number: 8830553
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: (01)04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/30/2026

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-3572
• Device Catalogue Number: BSM-3572A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2017
• 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 (PU-621RA); CNS (PU-621RA)
• Patient Sex: Unknown