Sedline® Seditation Monitor 9513Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Masimo Sedline monitor is a full-headset EEG used to track a patient's depth of anesthesia during surgery. Most of the 37 reports describe the monitor giving wrong or frozen readings, or cables and modules failing mid-surgery so the anesthesiologist could not judge the patient's depth; some mention patients becoming more awake than expected. There are no deaths and no reported injuries, and no recalls name this device. Reports rose from 1 in the previous 12 months to 11 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00843997009096), received between May 3, 2017 and Sep 24, 2026 — classified as 38 malfunctions.
The most frequently reported specific device problem is “High Readings” (12 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.
Reports received per month
Most reported problems
Device problems
- High Readings12
- Incorrect Measurement9
- Low Readings6
- Failure to Sense5
- Incorrect, Inadequate or Imprecise Result or Readings4
- Device Operates Differently Than Expected1
- Device Sensing Problem1
- Device Stops Intermittently1
Patient problems
- No Consequences Or Impact To Patient24
- Increased Level of Consciousness7
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Incorrect Measurement
The customer reported "sedline plug-in module indicating that a patient experienced anesthesia awareness during surgery. The anesthesiologist indicated the psi of the sedline module was at 20 but further information was not available. The patient was discharged from the monitor, which was not connected to a central station." There was no patient impact or consequence reported.
Patient problems: Increased Level of Consciousness
MAUDE report 50878075 ↗MalfunctionJul 6, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
PATIENT 5/5: THE CUSTOMER HAS REPORTED THERE HAS BEEN SEVERAL COMPLAINTS OF THE DEVICE NOT RECORDING CORRECTLY. "ALSO, SEDLINE DISPLAYING ERRONEOUS PSI READINGS, SUCH AS VERY LOW PSI VALUES DESPITE THE PATIENT BEING AWAKE AND ABLE TO OPEN THEIR EYES. THIS HAS OCCURRED ON NUMEROUS OCCASIONS, AND THE DEVICES HAVE DEMONSTRATED SIGNIFICANT INCONSISTENCY IN THEIR READINGS. ALSO, PSI VALUES REMAINING FIXED AT 25 FOR A PROLONGED PERIOD DESPITE SUBSTANTIAL CHANGES IN BOTH SURGICAL STIMULATION AND THE LEVEL OF ANAESTHESIA ADMINISTERED".
Patient problems: Increased Level of Consciousness
MAUDE report 25713404 ↗MalfunctionJul 6, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
PATIENT 4/5: THE CUSTOMER HAS REPORTED THERE HAS BEEN SEVERAL COMPLAINTS OF THE DEVICE NOT RECORDING CORRECTLY. "ALSO, SEDLINE DISPLAYING ERRONEOUS PSI READINGS, SUCH AS VERY LOW PSI VALUES DESPITE THE PATIENT BEING AWAKE AND ABLE TO OPEN THEIR EYES. THIS HAS OCCURRED ON NUMEROUS OCCASIONS, AND THE DEVICES HAVE DEMONSTRATED SIGNIFICANT INCONSISTENCY IN THEIR READINGS. ALSO, PSI VALUES REMAINING FIXED AT 25 FOR A PROLONGED PERIOD DESPITE SUBSTANTIAL CHANGES IN BOTH SURGICAL STIMULATION AND THE LEVEL OF ANAESTHESIA ADMINISTERED".
Patient problems: Increased Level of Consciousness
MAUDE report 25713387 ↗MalfunctionJul 6, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
PATIENT 2/5: THE CUSTOMER REPORTED SEDLINE DISPLAYING ERRONEOUS PSI READINGS, SUCH AS VERY LOW PSI VALUES DESPITE THE PATIENT BEING AWAKE AND ABLE TO OPEN THEIR EYES. THIS HAS OCCURRED ON NUMEROUS OCCASIONS, AND THE DEVICES HAVE DEMONSTRATED SIGNIFICANT INCONSISTENCY IN THEIR READINGS. PSI VALUES REMAINING FIXED AT 25 FOR A PROLONGED PERIOD DESPITE SUBSTANTIAL CHANGES IN BOTH SURGICAL STIMULATION AND THE LEVEL OF ANESTHESIA ADMINISTERED. "TWO PATIENTS OPENED THEIR EYES AFTER STOPPING ANAESTHETIC BUT PSI NUMBER REMAINED AT 30 FOR SIGNIFICANTLY LONG PERIOD OF TIME AFTER THAT. WE ARE ALL AWARE THAT THERE'S A BIT OF LAG TIME WITH THE PRCESSED EEG TECHNOLOGY INCLUDING BIS AND PSI (I THINK APPROX 30 SEC). BUT I BELIEVE THE LAG PERIOD WAS SIGNIFICANTLY LONG IN BOTH HIS CASES."
Patient problems: Increased Level of Consciousness
MAUDE report 25713310 ↗MalfunctionJul 5, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
PATIENT 1/5: THERE HAVE BEEN SEVERAL COMPLAINTS OF THE DEVICE NOT RECORDING CORRECTLY. THE CUSTOMER REPORTED PERSISTENT AND INCONSISTENT SEDLINE PSI/SEF READINGS (FALSELY LOW OR FIXED VALUES, PROLONGED LAG) THROUGHOUT CASE LEADING TO INAPPROPRIATE ANESTHETIC TITRATION AND A SPECIFIC INCIDENT WHERE THE PATIENT AWOKE IMMEDIATELY AFTER 500MG SUGAMMADEX WITH TIVA RUNNING AND REACHED FOR ETT.
Patient problems: Increased Level of Consciousness
MAUDE report 25713121 ↗MalfunctionJun 12, 2026Failure to Sense
THE CUSTOMER REPORTED "WE ARE SEEING 3-5 SEDLINE CABLE FAILURES A WEEK THAT IMPACT SURGERY IN REAL TIME. THE SEDLINE MODULE AND CABLE EXPERIENCE FAILURES THAT CAUSE THE MD TO BE UNABLE TO EVALUATE THE PATIENT'S DEPTH OF ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481452 ↗MalfunctionJun 12, 2026Failure to Sense
THE CUSTOMER REPORTED "WE ARE SEEING 3-5 SEDLINE CABLE FAILURES A WEEK THAT IMPACT SURGERY IN REAL TIME. THE SEDLINE MODULE AND CABLE EXPERIENCE FAILURES THAT CAUSE THE MD TO BE UNABLE TO EVALUATE THE PATIENT'S DEPTH OF ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481436 ↗MalfunctionJun 12, 2026Failure to Sense
THE CUSTOMER REPORTED "WE ARE SEEING 3-5 SEDLINE CABLE FAILURES A WEEK THAT IMPACT SURGERY IN REAL TIME. THE SEDLINE MODULE AND CABLE EXPERIENCE FAILURES THAT CAUSE THE MD TO BE UNABLE TO EVALUATE THE PATIENT'S DEPTH OF ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481422 ↗MalfunctionJun 12, 2026Failure to Sense
THE CUSTOMER REPORTED "WE ARE SEEING 3-5 SEDLINE CABLE FAILURES A WEEK THAT IMPACT SURGERY IN REAL TIME. THE SEDLINE MODULE AND CABLE EXPERIENCE FAILURES THAT CAUSE THE MD TO BE UNABLE TO EVALUATE THE PATIENT'S DEPTH OF ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481413 ↗MalfunctionJun 12, 2026Failure to Sense
THE CUSTOMER REPORTED "WE ARE SEEING 3-5 SEDLINE CABLE FAILURES A WEEK THAT IMPACT SURGERY IN REAL TIME. THE SEDLINE MODULE AND CABLE EXPERIENCE FAILURES THAT CAUSE THE MD TO BE UNABLE TO EVALUATE THE PATIENT'S DEPTH OF ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25481375 ↗MalfunctionApr 9, 2026High Readings
THE CUSTOMER REPORTED THAT ALL VALUES SHOW ABNORMALLY HIGH. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825456 ↗MalfunctionMar 30, 2026Low Readings
THE CUSTOMER REPORTED THAT THERE WAS A RECENT CASE OF A PATIENT EXPERIENCING AWARENESS UNDER GA, WITH SEDLINE RANGE REPORTING <45. IT WAS AN EMERGENCY CASE UNDER TIVA. A LONG CASE. PATIENT WAS STABLE. TOWARDS THE END OF THE CASE, ABOUT 30MINS BEFORE END, ANESTHETIST SWITCHED FROM PROPOFOL TO SEVOFLURANE, WHICH WAS THEIR USUAL PRACTICE. PATIENT LATER REPORTED THAT THEY FELT ALL OF THE SUTURING. PSI REPORTED TO ALWAYS BE BELOW 45.
Patient problems: Increased Level of Consciousness
MAUDE report 24710065 ↗MalfunctionOct 21, 2025Low Readings; Low Readings
THE CUSTOMER REPORTED THAT IN BETWEEN SURGERY "WHEN THE PSI WAS 21, [THE] PATIENT GAINED CONSCIOUSNESS AND ALL OF A SUDDEN 'SELF-EXTUBATED HIMSELF' AND STARTED MOVING WHILE PSI WAS STILL 20". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: Increased Level of Consciousness
MAUDE report 23354151 ↗MalfunctionApr 10, 2020High Readings; High Readings
THE CUSTOMER REPORTED THE SEDLINE MODULE DOES NOT DETECT PROPERLY, UNRELIABLE OVERESTIMATED MEASUREMENTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9950282 ↗MalfunctionFeb 14, 2020Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE SEDLINE DOES NOT WORK WELL. THE CLAIM IS ABOUT WRONG VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9714871 ↗MalfunctionJan 27, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THE SEDLINE MODULE STOPPED WORKING DURING A CASE IN THE OR. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9634944 ↗MalfunctionSep 27, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE MEASUREMENTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9132097 ↗MalfunctionJul 17, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED WHILST THE SEDLINE SENSOR WAS ON THE PATIENT, THE PSI DROPPED DOWN TO AS LOW AS 30. IT THEN RETURNED TO READINGS OF AROUND 90 BEFORE DROPPING AGAIN TO 44. THE PATIENT CABLE WAS DISCONNECTED AND RECONNECTED AND THE CASE CONTINUED WITH NO PROBLEMS AND ACCEPTABLE PSI READINGS FOR SEDATION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8798912 ↗MalfunctionJun 28, 2019High Readings; High Readings
THE CUSTOMER REPORTED THE PSI VALUE DID NOT GO DOWN INTO NORMAL RANGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8746274 ↗MalfunctionJun 27, 2019High Readings; High Readings
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED HIGH READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8741507 ↗MalfunctionJun 24, 2019High Readings; High Readings
THE CUSTOMER REPORTED THE PSI WAS HIGHER THAN THE NORMAL RANGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8729701 ↗MalfunctionApr 22, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED INACCURATE MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8536128 ↗MalfunctionApr 10, 2019Device Sensing Problem; Device Sensing Problem
THE CUSTOMER REPORTED THE SEDLINE (PSI) NUMBER IS DROPPING OUT AND NOT SHOWING ON THE SCREEN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8502166 ↗MalfunctionDec 13, 2018High Readings; High Readings
THE CUSTOMER REPORTED THE PSI VALUE IS OVER 60, BUT THEY CHANGED OTHER MODULES ITS VALUE WAS NORMAL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8162821 ↗MalfunctionDec 13, 2018High Readings; High Readings
THE CUSTOMER REPORTED THE PSI VALUE WAS HIGH. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8162805 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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