MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN SVM-7200 SERIES VITAL SIGNS MONITOR

Model Number	SVM-7260
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nibp readings were inconsistently not in specifications.The nurse just could not get accurate readings and at time no readings.Sometimes monitor would just keep pumping, so they would shut it off and use another monitor.The biomedical engineer (bme) brought it to the shop and connected to one of their pronk simulator cubes.This test device will run blood pressure, ecg, and spo2 simulated functions.When running bp simulations a normal reading of 120/80, the specifications's are + or - 3.This monitor would only get one or two readings in specification.Then the next few would-be way out of specification range.They could not get enough of them within specification readings consistently.Also, the pump makes erratic, strange or unusual sounds.Not in patient use.
Additional Manufacturer Narrative
The customer reported that the nibp readings were inconsistently not in specifications.The nurse just could not get accurate readings and at time no readings.Sometimes monitor would just keep pumping, so they would shut it off and use another monitor.The biomedical engineer (bme) brought it to the shop and connected to one of their pronk simulator cubes.This test device will run blood pressure, ecg, and spo2 simulated functions.When running bp simulations a normal reading of 120/80, the specifications's are + or - 3.This monitor would only get one or two readings in specification.Then the next few would-be way out of specification range.They could not get enough of them within specification readings consistently.Also, the pump makes erratic, strange or unusual sounds.Not in patient use.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 Manufacturer Narrative
The customer reported that the nibp readings were inconsistently not in specifications.The nurse just could not get accurate readings and at time no readings.Sometimes monitor would just keep pumping, so they would shut it off and use another monitor.The biomedical engineer (bme) brought it to the shop and connected to one of their pronk simulator cubes.This test device will run blood pressure, ecg, and spo2 simulated functions.When running bp simulations a normal reading of 120/80, the specificationss are + or - 3.This monitor would only get one or two readings in specification.Then the next few would be way out of specification range.They could not get enough of them within specification readings consistently.Also, the pump makes erratic, strange or unusual sounds.Not in patient use.Investigation conclusion: the customer reported a device (svm-7260a-t1w, sn: (b)(6)) with inconsistent blood pressure readings, and a pump that makde erratic sounds.The complaint device was returned to nihon kohden for evaluation and repair.The repair technician observed some minor damage to the unit and duplicated the reported problem.The root cause was determined to be failing hardware, and the pump and valve were replaced.The complaint device performed to the manufacturer's specifications after component replacement.
Event or Problem Description
The customer reported that the nibp readings were inconsistently not in specifications.The nurse just could not get accurate readings and at time no readings.Sometimes monitor would just keep pumping, so they would shut it off and use another monitor.The biomedical engineer (bme) brought it to the shop and connected to one of their pronk simulator cubes.This test device will run blood pressure, ecg, and spo2 simulated functions.When running bp simulations a normal reading of 120/80, the specificationss are + or - 3.This monitor would only get one or two readings in specification.Then the next few would be way out of specification range.They could not get enough of them within specification readings consistently.Also, the pump makes erratic, strange or unusual sounds.Not in patient use.

• Brand Name: NIHON KOHDEN SVM-7200 SERIES VITAL SIGNS MONITOR
• Common Device Name: VITAL SIGNS 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 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: 22722730
• Report Number: 8030229-2025-05261
• Device Sequence Number: 8888042
• Product Code: DXN
• UDI-Device Identifier: 04931921005903
• UDI-Public: (01)04931921005903
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K190468
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2025

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: SVM-7260
• Device Catalogue Number: SVM-7260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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