BIS Module IntelliVue BIS ModuleRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00884838051515), received between May 10, 2022 and May 27, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON AN M_BIS BISX POWER LINK INDICATING THAT THE UNIT WAS PROVIDING AN EQUIPMENT MALFUNCTION AND NO LONGER PROVIDING ACCURATE READINGS. 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 25306719 ↗
• MalfunctionApr 20, 2026Low Readings

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE BIS MODULE INDICATING THAT THE THAT THE MEASURED VALUES WERE LOW. 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 24929470 ↗
• MalfunctionApr 8, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE MEASUREMENT VALUES WERE LOW. 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 24823714 ↗
• MalfunctionMar 20, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE BIS MODULE INDICATING THAT THE DISPLAYED VALUES DO NOT CORRESPOND TO THE ADMINISTERED SEDATION. 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 24651120 ↗
• MalfunctionMay 8, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETIZED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF SPECTRAL EDGE FREQUENCY ANOTHER INDICATOR OF ADEQUATE ANESTHESIA. THE USE OF DEPTH OF ANESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANESTHETIC AGENTS, AND THUS MINIMIZE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL. 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 16888767 ↗
• MalfunctionMay 8, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETIZED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANESTHESIA. THE USE OF DEPTH OF ANESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANESTHETIC AGENTS, AND THUS MINIMIZE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL. 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 16885781 ↗
• MalfunctionMay 8, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETIZED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANESTHESIA. THE USE OF DEPTH OF ANESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANESTHETIC AGENTS, AND THUS MINIMIZE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL. 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 16885433 ↗
• MalfunctionMay 8, 2023Increase in Pressure; High Test Results; Increase in Pressure; High Test Results

  THE SEDLINE DEVICE IS A DEPTH OF ANESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETIZED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANESTHESIA. THE USE OF DEPTH OF ANESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANESTHETIC AGENTS, AND THUS MINIMIZE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL. 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 16885359 ↗
• MalfunctionMay 8, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETIZED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANESTHESIA. THE USE OF DEPTH OF ANESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANESTHETIC AGENTS, AND THUS MINIMIZE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL. 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 16885349 ↗
• MalfunctionMay 8, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANAESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETISED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANAESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANAESTHESIA. THE USE OF DEPTH OF ANAESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANAESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANAESTHETIC AGENTS, AND THUS MINIMISE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANAESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885220 ↗
• MalfunctionMay 8, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETIZED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANESTHESIA. THE USE OF DEPTH OF ANESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANESTHETIC AGENTS, AND THUS MINIMIZE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL. 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 16884985 ↗
• MalfunctionMay 8, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANAESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETISED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANAESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANAESTHESIA. THE USE OF DEPTH OF ANAESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANAESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANAESTHETIC AGENTS, AND THUS MINIMISE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANAESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16884813 ↗
• MalfunctionMay 5, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANAESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETISED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANAESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANAESTHESIA. THE USE OF DEPTH OF ANAESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANAESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANAESTHETIC AGENTS, AND THUS MINIMISE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANAESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16880024 ↗
• MalfunctionMay 5, 2023Increase in Pressure; High Readings; Increase in Pressure; High Readings

  THE SEDLINE DEVICE IS A DEPTH OF ANAESTHESIA MONITOR. IT ANALYSES THE EEG OF THE ANAESTHETISED PATIENT. THIS ANALYSIS IS DISPLAYED AS A PSI NUMBER. THE RANGE 25-50 IS SUGGESTED TO SHOW ADEQUATE SURGICAL ANAESTHESIA. THE RAW EEG IS ALSO DISPLAYED, AS IS THE SEF - SPECTRAL EDGE FREQUENCY - ANOTHER INDICATOR OF ADEQUATE ANAESTHESIA. THE USE OF DEPTH OF ANAESTHESIA DEVICES IS RECOMMENDED WITH TOTAL INTRAVENOUS ANAESTHESIA TO PREVENT AWARENESS DURING SURGERY. THEY ARE ALSO CONSIDERED USEFUL TO PREVENT OVERDOSAGE OF ANAESTHETIC AGENTS, AND THUS MINIMISE THE CHANCE OF POST OPERATIVE COGNITIVE DYSFUNCTION. THE PSI DISPLAYED BY SEDLINE IS PROVING UNRELIABLE. THE NUMBER SPONTANEOUSLY CLIMBS, SUGGESTING INADEQUATE ANAESTHESIA, WHILST ALL OTHER CLINICAL SIGNS REMAIN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16880005 ↗
• MalfunctionMay 10, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED A FAILURE TO ALARM FOR THE DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346163 ↗