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

Model Number	SVM-7250
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the nipb module for the vital signs monitor was reading about 10 points too high and the readings were inconsistent.They were using nk cables and cuffs.The device was not in patient use at the time.Investigation summary: the complaint device was returned to nihon kohden (nk) for evaluation and repair.The reported complaint was duplicated, as the pump was not functioning normally.Nk confirmed that the reported incident stemmed from a component failure, as the pump needed replacement due to wear and tear damage over time.In this case, the device was installed at the facility on 09/30/2024, indicating it has aged approximately one year.Aging devices and their components are susceptible to wear and tear damage from mechanical stress due to frequency of use in conjunction with possible user errors from mishandling, misuse by possibly dropping the device, and a possible lack of preventative maintenance.The repaired device was shipped back to the customer.This is an isolated incident at this facility, and there has been no recurrence of this issue since the reported date.Trending for similar issues and devices will continue to be monitored by nk.
Event or Problem Description
The biomedical engineer (bme) reported that the nipb module for the vital signs monitor was reading about 10 points too high and the readings were inconsistent.They were using nk cables and cuffs.The device was not in patient use at the time.

• 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: 22485131
• Report Number: 8030229-2025-05172
• Device Sequence Number: 7943183
• Product Code: DXN
• UDI-Device Identifier: 04931921005897
• UDI-Public: (01)04931921005897
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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-7250
• Device Catalogue Number: SVM-7250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2020
• 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