Nihon Kohden SVM-7200 Series Vital Signs Monitor SVM-7260Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04931921005903), received between Oct 4, 2024 and Sep 30, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948180 ↗
• MalfunctionAug 7, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176254 ↗
• MalfunctionAug 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22722730 ↗
• MalfunctionJul 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414184 ↗
• MalfunctionJul 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413747 ↗
• MalfunctionJul 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387152 ↗
• MalfunctionOct 4, 2024Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20367150 ↗