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	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: the customer reported that the vital sign monitors were not properly taking nibp readings, and the pump sounded like it was giving out.The readings would always be way too high and had to be double checked manually by med surge staff during preventative maintenance.They did not know what the incorrect readings or expected readings were supposed to be.They did mention the readings were in the 200/90+ range.They were using 3rd party welch allyn quick connect cuffs which are not approved to be used with nk devices.There was no patient harm reported.Investigation summary: the complaint device was returned to nk for evaluation and repair.Repair the technician duplicated the reported problem of "nibp issue." the root cause was determined to be failing hardware, and the pump and valve were replaced.A serial number review of the reported device reveals one similar complaint of nibp issues (ticket (b)(4)), for which it was noted that there was likely a compatibility issue with the customer's welch allyn cuffs and nk nibp hoses.Per the svm operator's manual, the maximum safety and performance from the monitor cannot be achieved with the use of unspecified cuffs.A review of the customer's complaint history shows a total of six complaints issued for svm nibp-related issues.Nk will continue to trend and monitor.
Event or Problem Description
The customer reported that the vital sign monitors were not properly taking nibp readings, and the pump sounded like it was giving out.They mentioned that the readings were in the 200/90+ range.There was no patient harm reported.

• 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: 22387152
• Report Number: 8030229-2025-05138
• Device Sequence Number: 20577759
• Product Code: DXN
• UDI-Device Identifier: 04931921005903
• UDI-Public: (01)04931921005903
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 07/02/2025

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
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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: NA.
• Patient Sex: Unknown