BIS PMB4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521808270), received between Mar 2, 2025 and Jun 26, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Readings” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025High Readings; High Readings

  IT WAS REPORTED THAT DURING USE OF THE MONITOR, THE VALUE WAS REPORTED AS INACCURATE, WITH A HIGH READING OF 73. CONCERNS WERE RAISED THAT ELEVATED INDEX VALUES WERE OCCURRING MORE FREQUENTLY ON THE ADVANCE MONITOR. NO ERROR MESSAGES APPEARED ON THE MONITOR. THE USER DETERMINED THE VALUE WAS INCORRECT BASED ON OBSERVATION OF THE PATIENT, REVIEW OF MINIMUM ALVEOLAR CONCENTRATION (MAC), AND REVIEW OF ANAESTHETIC DELIVERY. IT WAS UNKNOWN IF THERE WAS ANY PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22333896 ↗
• MalfunctionApr 28, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE HAD AN INACCURATE SENSOR CHECK VALUE DURING TESTING AND NO BASELINE NEED TO BE SET FOR TEST SENSOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922630 ↗
• MalfunctionApr 18, 2025High Readings; Low Readings; High Readings; Low Readings

  IT WAS REPORTED THAT DURING THE USE, THE MONITOR READINGS WERE HIGH WHILE THE PATIENT WAS DEEPLY UNCONSCIOUS AND LOW WHEN THE PATIENT APPEARED TO BECOME AWAKE. AFTER THE ANESTHETIST NOTICING THE INACCURACY WITH THE FIRST SENSOR, IT WAS REPLACED WITH ANOTHER NEW SENSOR BUT HAD SAME RESULT. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866302 ↗
• MalfunctionMar 2, 2025Insufficient Heating; Temperature Problem; Insufficient Heating; Temperature Problem

  IT WAS REPORTED THAT PRIOR TO USE, A DEVICE BECAME HOT WHEN PLUGGED INTO THE DOCKING STATION, WITH THE UNIT REACHING TEMPERATURES OVER 117 DEGREES. THE DEVICE AND DOCKING STATION WERE NOTED TO BECOME HOT TO THE TOUCH WHEN CHARGING UP TO 100%. ALTHOUGH THE DEVICE EXCEEDED TEMPERATURE LIMITS WHILE CHARGING, IT COOLED DOWN UPON REACHING FULL CHARGE. TROUBLESHOOTING STEPS INCLUDED WALKING THE CUSTOMER AND REPRESENTATIVE THROUGH THE PROCESS, REPLACING DOCKING STATIONS, AND TESTING BY A REPRESENTATIVE ON-SITE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501292 ↗
• MalfunctionMar 2, 2025Insufficient Heating; Temperature Problem; Insufficient Heating; Temperature Problem

  IT WAS REPORTED THAT PRIOR TO USE, A DEVICE BECAME HOT WHEN PLUGGED INTO THE DOCKING STATION, REACHING TEMPERATURES OVER 117 DEGREES. THE DEVICE AND DOCKING STATION WERE NOTED TO BECOME HOT TO THE TOUCH WHEN CHARGING UP TO 100%. ALTHOUGH THE DEVICE EXCEEDED TEMPERATURE LIMITS WHILE CHARGING, IT COOLED DOWN UPON REACHING FULL CHARGE. TROUBLESHOOTING STEPS INCLUDED WALKING THE CUSTOMER AND REPRESENTATIVE THROUGH THE PROCESS, REPLACING DOCKING STATION, AND TESTING BY A REPRESENTATIVE ON-SITE. DESPITE THESE EFFORTS, THE DEVICE CONTINUED TO OVERHEAT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21501291 ↗