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

Model Number	SVM-7260
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Details of complaint: on 06/27/2024, the customer reported that their vital sign monitor (svm) (model: svm-7260a-t1w, serial number: (b)(6) provided an inaccurate non-invasive blood pressure (nibp) reading.The customer requested an exchange.There was patient involvement when the issue occurred, but no report of patient harm, no injury, nor any adverse event, due to the reported issue.Investigation summary: on 09/04/2024, the svm device was returned and evaluated by the nk repair center.The reported issue ("inaccurate nibp reading") was duplicated and confirmed.A definitive root cause could not be determined.However, upon evaluation, the repair center found the following parts to be faulty and required replacing: the nibp valve, pump, cracked front enclosure, and cracked rear enclosure.Nibp is a noninvasive determination of blood pressure and is used in conjunction with information obtained from other vitals and ecg to determine the patient's status.The risk of nibp failure is that there is a loss of monitoring of blood pressure for one patient.The bedside monitor will retain the ability to monitor the remaining vital signs and cardiac rhythm, as well as to generate alarms and transmit signal to a cns.Nibp failures may result from device damage or broken components including damaged buttons on the control panel, broken nibp sockets on the bedside device, or physical damage impacting internal components (e.G., pump, dpu, power bd, digital bd).Issues may arise due to wear and tear of the nibp components resulting in nibp circuit failure, pump failure or stuck solenoid.User errors may contribute to failure modes or false alarms with nibp readings such as the cuff being wrapped too tightly or loosely, the hose or line not connected properly, a bent hose, or nibp being performed concurrently with ibp measurement or incorrect user settings such at time interval or pwtt (pulse wave transit time) setup, measurements being performed on the wrong side or the measurement set to "auto" mode.Incompatible cuff or hose may also affect use and/or readings.Patient conditions that could contribute to nibp issues or inaccurate readings include body movement, or when a pulse wave is not detectable.A serial number review of the reported device (model: svm-7260a-t1w, serial number: (b)(6) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.
Event or Problem Description
The customer reported the vital signs monitor (svm) had incorrect non-invasive blood pressure (nibp) readings while in patient use.No patient harm was 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: 20367150
• Report Number: 8030229-2024-04463
• Device Sequence Number: 14375004
• Product Code: MWI
• UDI-Device Identifier: 04931921005903
• UDI-Public: (01)04931921005903
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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: 07/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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