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

Model Number	BSM-3572
Medical Device Problem Codes	High Test Results (2457); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the ekg vitals are spiking on this bedside monitor (bsm).The bsm monitors the ekg vitals from a telemetry unit.According to the customer, the readings begin to spike passed 100/120 after about 15-20 minutes while the telemetry unit is reading 70/80.The customer tested the equipment with another bsm and had no issues.There was no patient injury 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(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 10/07/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 10/13/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.Attempt # 3: 10/17/2025 i called (b)(6) to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for (b)(6) to call me back with this information.
Event or Problem Description
The customer reported that the ekg vitals are spiking on this bedside monitor (bsm).There was no patient injury reported.
Event or Problem Description
The customer reported that the ekg vitals are spiking on this bedside monitor (bsm).There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the ekg vitals are spiking on this bedside monitor (bsm).The bsm monitors the ekg vitals from a telemetry unit.According to the customer, the readings begin to spike passed 100/120 after about 15-20 minutes while the telemetry unit is reading 70/80.The customer tested the equipment with another bsm and had no issues.There was no patient injury reported.Investigation summary: the device was returned for evaluation.During testing of the unit, the reported issue was duplicated.The root cause for the reported issue was determined to be failure of internal components.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 10/07/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 10/13/2025 i called deisy to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for deisy to call me back with this information.Attempt # 3: 10/17/2025 i called deisy to ask for model and serial numbers of any devices the reported device was connected or related to.A message was left for deisy to call me back with this information.Additional information: b4 date of this report.D9 is this device available for evaluation?.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type?.H3 device evaluated by manufacturer?.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: 23348509
• Report Number: 8030229-2025-05572
• Device Sequence Number: 20785340
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: (01)04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/05/2025

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-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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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