BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIHON KOHDEN SVM-7200 SERIES VITAL SIGNS MONITOR

    MDR report key: 23693366 · Received December 2, 2025

    Report

    Report Number
    8030229-2025-05811
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 6, 2025
    Report Date
    March 4, 2026
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DXN
    UDI-DI
    04931921005903
    PMA / PMN Number
    K190468
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE VITAL SIGNS MONITOR (SVM) WAS TAKING INACCURATE NON-INVASIVE BLOOD PRESSURE (NIBP) READINGS. THE READINGS WERE ALWAYS 120/80 ON EVERY PATIENT AND THE SIMULATOR EVEN WHEN THE SIMULATOR WAS SET FOR A VASTLY DIFFERENT READING. NO PATIENT HARM WAS REPORTED. INVESTIGATIONS SUMMARY: THE DEVICE WAS RETURNED TO NIHON KOHDEN FOR EVALUATION. DURING EVALUATION, THE REPORTED ISSUE OF ONLY READING 120/80 MMHG WAS NOT REPLICATED, BUT INACCURATE NIBP READINGS WERE OBSERVED. THE EXAMPLE PROVIDED WAS A READING OF 194/130 MMHG WHILE THE SIMULATOR WAS SET TO 190/120 MMHG. THE CAUSE OF THE MALFUNCTION WAS ATTRIBUTED TO A FAILURE IN THE PNEUMATIC SYSTEM, AND THE DEVICE'S PUMP AND VALVE WILL BE REPLACED AS A CORRECTIVE ACTION. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY BY SERIAL NUMBER REVEALS NO SIMILAR ISSUES. A SIGNIFICANT TREND HAS NOT BEEN OBSERVED THAT WOULD WARRANT ANY FURTHER CORRECTIVE ACTION NIHON KOHDEN WILL CONTINUE TO TREND AND MONITOR. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT. D9 DEVICE AVAILABLE FOR EVALUATION. G3 DATE RECEIVED BY MANUFACTURER. G6 TYPE OF REPORT. H2 IF FOLLOW-UP, WHAT TYPE?. H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES. H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE VITAL SIGNS MONITOR (SVM) WAS TAKING INACCURATE NON-INVASIVE BLOOD PRESSURE (NIBP) READINGS. THE READINGS WERE ALWAYS 120/80 ON EVERY PATIENT AND THE SIMULATOR EVEN WHEN THE SIMULATOR WAS SET FOR A VASTLY DIFFERENT READING. NO PATIENT HARM WAS 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.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE VITAL SIGNS MONITOR (SVM) WAS TAKING INACCURATE NON-INVASIVE BLOOD PRESSURE (NIBP) READINGS. THE READINGS WERE ALWAYS 120/80 ON EVERY PATIENT AND THE SIMULATOR EVEN WHEN THE SIMULATOR WAS SET FOR A VASTLY DIFFERENT READING. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE VITAL SIGNS MONITOR (SVM) WAS TAKING INACCURATE NON-INVASIVE BLOOD PRESSURE (NIBP) READINGS. THE READINGS WERE ALWAYS 120/80 ON EVERY PATIENT AND THE SIMULATOR EVEN WHEN THE SIMULATOR WAS SET FOR A VASTLY DIFFERENT READING. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958342 NIHON KOHDEN SVM-7200 SERIES VITAL SIGNS MONITOR VITAL SIGNS MONITOR DXN NIHON KOHDEN CORPORATION SVM-7260 NA 04931921005903

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.