EarlyVue VS30 EarlyVue VS30 Vitals monitorRecalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 00884838091412), received between Aug 25, 2020 and Sep 29, 2026 — classified as 2 injuries, 165 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (46 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Aug 31, 2023Class IIOpen, Classified

   A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.

   Z-2654-2023 · Root cause: Software design · Recall details · FDA record ↗

2. Mar 6, 2023Class IIOpen, Classified

   EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition.

   Z-1645-2023 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 167 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931172 ↗
• MalfunctionSep 28, 2026Imprecise or Erratic Results

  Philips received a complaint on an EarlyVue VS30 monitor indicating that the SpO2 was not reading correctly. The device was in clinical use at the time the issue was discovered. There was no adverse event or patient harm reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918153 ↗
• MalfunctionSep 27, 2026Device Fell

  Patient problems: Insufficient Information; Laceration(s)

  MAUDE report 50910385 ↗
• MalfunctionSep 24, 2026High Readings

  The customer reported that the monitor's diastolic value was higher than expected. The device was not in use on a patient at the time of event, there was no adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877226 ↗
• MalfunctionSep 10, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722083 ↗
• MalfunctionAug 27, 2026Imprecise or Erratic Results

  It was reported that the device is experiencing an accuracy issue involving a low SPO2 error. It is unknown if the device was in use on a patient at the time of the event. There was no adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476020 ↗
• MalfunctionAug 13, 2026Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235392 ↗
• MalfunctionJun 30, 2026High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE EARLYVUE VS30 VITALS MONITOR INDICATING THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP) WAS SHOWING HIGH IN THE SIMULATOR. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, SO THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25671439 ↗
• MalfunctionJun 30, 2026High Readings

  PHILIPS RECEIVED A COMPLAINT ON AN EARLYVUE VS30 INDICATING THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP) READINGS WERE HIGH. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664983 ↗
• MalfunctionJun 25, 2026High Readings

  PHILIPS RECEIVED A COMPLAINT ON AN EARLYVUE VS30 MONITOR INDICATING THAT THE NON-INVASIVE BLOOD PRESSURE (NIBP) DIASTOLIC IS READING INACCURATE AND VERY HIGH 90. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627274 ↗
• MalfunctionJun 18, 2026High Readings

  PHILIPS RECEIVED A COMPLAINT ON THE INDICATING THAT NBP READINGS WERE HIGHER THAN THOSE FROM MANUAL TESTING. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545806 ↗
• MalfunctionJun 16, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE EARLYVUE VS30 VITAL SIGNS MONITOR INDICATING THAT THE BLOOD PRESSURE WAS NOT WORKING. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25527035 ↗
• MalfunctionJun 16, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE EARLYVUE VS30 VITAL SIGNS MONITOR INDICATING THAT THE BLOOD PRESSURE WAS NOT WORKING. THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526966 ↗
• MalfunctionJun 9, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE MAP IS NOT ACCURATE ON THE DEVICE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439450 ↗
• MalfunctionJun 8, 2026No Audible Prompt/Feedback

  PHILIPS RECEIVED A COMPLAINT ON AN EARLYVUE VS30 INDICATING THAT AFTER REPLACING THE MAINBOARD FOR AN UNRELATED ISSUE, A SPEAKER MALFUNCTION ERROR WAS DISPLAYED. IT IS UNKNOWN IF THERE WAS AUDIBLE SOUND PRODUCED OR NOT. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435838 ↗
• MalfunctionJun 1, 2026High Readings

  IT WAS REPORTED THAT THE NBP BOTTOM NUMBER (DIASTOLIC) IS 10 POINTS TOO HIGH COMPARED TO OTHER DEVICES. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354154 ↗
• MalfunctionJun 1, 2026No Audible Alarm

  IT WAS REPORTED THAT THE DEVICE IS DISPLAYING AN ERROR CODE FOR A SPEAKER MALFUNCTION AND CONFIRMED NO SOUND. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354137 ↗
• MalfunctionJun 1, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE EARLYVUE VS30 INDICATING THAT THAT CLINICAL STAFF WERE QUESTIONING THE DIFFERENCE BETWEEN THE VS30 MONITOR'S MEASURED MAP (MEAN ARTERIAL PRESSURE) AND MANUALLY CALCULATED VALUES. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348172 ↗
• MalfunctionMay 29, 2026High Readings

  PHILIPS RECEIVED A COMPLAINT ON AN EARLYVUE VS30 INDICATING THE DEVICE HAS A HIGH DIASTOLIC BP AS COMPARED TO OTHER VS MONITORING DEVICES. IT WAS ALSO NOTED THAT THE DEVICE INFLATES TO 200 AND DEFLATES DOWN TO 2 AND THEN CYCLES. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333071 ↗
• MalfunctionMay 28, 2026Incorrect Measurement

  CUSTOMER REPORTED THAT THE UNIT IS STILL NOT REPORTING CORRECT VITALS. EVERY TEMPERATURE SAYS 102 AND SYSTOLIC BLOOD PRESSURE (BP) READS 20 POINTS HIGHER. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326203 ↗
• MalfunctionMay 21, 2026Low Readings

  PHILIPS RECEIVED A COMPLAINT ON AN EARLYVUE VS30 DEVICE INDICATING THAT THE DIASTOLIC BLOOD PRESSURE IS MEASURING LOW. WHEN NON-INVASIVE BLOOD PRESSURE (NIBP) IS TAKEN IT MANUALLY THEY GET A MUCH DIFFERENT READING. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241283 ↗
• MalfunctionMay 21, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT BLOOD PRESSURE NOT READING WHEN SET TO LOW MEASUREMENTS. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238224 ↗
• MalfunctionMay 20, 2026High Readings

  IT WAS REPORTED THAT THE DEVICE IS PROVIDING A DIASTOLIC VALUE THAT IS TOO HIGH. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229686 ↗
• MalfunctionMay 20, 2026Incorrect Measurement

  THE CUSTOMER REPORTED INCORRECT BLOOD PRESSURE READINGS ON THE DEVICE, OCCURRING RANDOMLY OUT OF 5 CHECKS. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226311 ↗
• MalfunctionMay 19, 2026High Readings

  IT WAS REPORTED THAT THE BLOOD PRESSURE (BP) READINGS PROVIDED ARE HIGH. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215597 ↗