SedLine™ EEG Sensor 2479Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10843997005804), received between Aug 18, 2017 and Mar 6, 2019 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2019Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE "NURSE COULDN'T DETECT R2 AND L2, AND R1,CT, L2 MEASUREMENTS WERE NOT ACCURATE." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8396301 ↗
• MalfunctionApr 28, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED: "PSI VALUE SHOWS OVER 80 EVEN THOUGH PATIENT IS WELL ANESTHETIZED". NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471278 ↗
• MalfunctionApr 28, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED: "PSI VALUE SHOWED OVER 85 AND EMG SHOWED 65% THEN IT IS MAINTAINED PSI AT 80 AND EMG AT 60% EVEN THOUGH PATIENT IS WELL ANESTHETIZED". NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471277 ↗
• MalfunctionApr 8, 2018High Readings; High Readings

  THE CUSTOMER REPORTED PSI VALUE DOESN'T SEEM ACCURATE. ADDITIONALLY, THE VALUES WENT UP TO AROUND 80 WITHOUT OTHER SIGNS OF WAKING UP OR MUSCLE MOVEMENT. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7405772 ↗
• MalfunctionApr 8, 2018High Readings; High Readings

  THE CUSTOMER REPORTED PSI VALUE DOESN'T SEEM ACCURATE. ADDITIONALLY, THE VALUES WENT UP TO AROUND 80 WITHOUT OTHER SIGNS OF WAKING UP OR MUSCLE MOVEMENT. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7405771 ↗
• MalfunctionMar 26, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED "HIGH PSI VALUE WAS DISPLAYED BY ROOT WHILE PATIENT WAS ENOUGH ANESTHETIZED." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372419 ↗
• MalfunctionJan 31, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED "PSI SHOWS TOO HIGH VALUE WHILE PATIENT WAS ANESTHETIZED." NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7233096 ↗
• MalfunctionNov 20, 2017Device Stops Intermittently; Device Stops Intermittently

  IT WAS REPORTED BY MASIMO CLINICAL SPECIALIST: "AT SOME POINT DURING THE CARDIAC SURGERY, THE PATIENT STARTED TO SWEAT MASSIVELY, VEGETATIVELY. THE SEDLINE SENSOR ALL OF A SUDDEN COULDN¿T GET A PROPER EEG READING ANYMORE, THE SENSOR¿S ELECTRODES SAID TO HAVE HIGH IMPEDANCE ON THE ROOT MONITOR FOR A VERY SHORT TIME AND THEN CONTINUED TO BE GREEN ON THE MONITOR WHICH MEANS THE SENSOR HAS NORMAL IMPEDANCE AND GETS EEG DATA. NEVERTHELESS, THE MONITOR SHOWED A HIGH NUMBER OF ARTIFACTS, AT A 100%. TOGETHER WITH THE ANESTHETIST WE COULD EXCLUDE EXTERNAL REASONS FOR HAVING THOSE ARTIFACTS LIKE ELECTROCAUTERY OR MANIPULATION CLOSE TO THE SENSOR ITSELF. THEN, I DISCONNECTED THE SEDLINE SENSOR FROM THE PATIENT CABLE AND COULD SEE IT WAS SEVERELY WET FROM THE PATIENT SWEATING EXTREMELY. WE DRIED THE CONNECTION AND RECONNECTED IT, BY THEN THE EEG READING WAS OK AGAIN AND WE COULD SEE THE DSA ALSO. NOW, WE COULD SEE EXTERNAL INTERFERENCES IN THE DSA THAT SHOWED UP ALL OF A SUDDEN. SINCE THE SETTING IN THE OR HAS NOT CHANGED AND THE ROOT MONITOR WAS ON THE SAME PLACE THAN BEFORE AND EVEN GROUNDED WE COULD NOT SEE THE SOURCE OF INTERFERENCES. BY LOOKING AT THE IMPEDANCE ALL THE TIME IT WAS ¿GREEN¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7045810 ↗
• MalfunctionAug 19, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED PATIENT IS ANESTHETIZED ENOUGH BUT PSI SHOWED HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806494 ↗
• MalfunctionAug 19, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED PATIENT IS ANESTHETIZED ENOUGH BUT PSI SHOWED HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806473 ↗
• MalfunctionAug 19, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED PATIENT IS ANESTHETIZED ENOUGH BUT PSI SHOWED HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806466 ↗
• MalfunctionAug 19, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED PSI TOO HIGH WHILE PATIENT WAS ANESTHETIZED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806458 ↗
• MalfunctionAug 19, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED PSI TOO HIGH DURING USE (MORE THAN 90 THOUGH PT. WAS WELL ANESTHETIZED). NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806442 ↗
• MalfunctionAug 18, 2017High Readings; High Readings

  THE CUSTOMER REPORTED PATIENT IS ANESTHETIZED ENOUGH BUT PSI SHOWED HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6805908 ↗