RD SedLine 4248Recalls & reported problems
Masimo Corporation · EEG Sensor Adult · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Masimo SedLine EEG sensor is a sensor placed on the forehead to measure brain activity during anesthesia. Many of the 82 reports describe readings that are too high or incorrect, sometimes showing an awake state during anesthesia. The reports include no injuries and no deaths. No recalls name this device.
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
- 86
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10843997011775), received between May 10, 2018 and Sep 26, 2026 — classified as 86 malfunctions.
The most frequently reported specific device problem is “High Readings” (48 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 Readings48
- Incorrect Measurement32
- Low Readings3
- Unable to Obtain Readings2
- Improper or Incorrect Procedure or Method1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Sensing Intermittently1
Patient problems
- No Consequences Or Impact To Patient77
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907629 ↗MalfunctionSep 26, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907626 ↗MalfunctionSep 26, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907625 ↗MalfunctionSep 26, 2026High Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907622 ↗MalfunctionApr 21, 2026High Readings
THE CUSTOMER REPORTED THAT THE PATIENT WAS INDUCED INTO SLEEP DURING APPLICATION; HOWEVER, DESPITE OBSERVING THE MONITOR FOR OVER 15 MINUTES, THE READINGS REMAINED UNCHANGED AT AROUND 90¿85. AFTER REPLACING THE DEVICE, NORMAL MEASUREMENTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948497 ↗MalfunctionMar 7, 2026High Readings
THE CUSTOMER REPORTED DURING ANESTHESIA, VALUES INDICATIVE OF AN AWAKE STATE WERE OBSERVED. AFTER REPLACING THE CONSUMABLE, READINGS RETURNED TO LEVELS CONSISTENT WITH ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541183 ↗MalfunctionFeb 23, 2026High Readings
THE CUSTOMER REPORTED THAT DURING ANESTHESIA, VALUES INDICATIVE OF AN AWAKE STATE WERE OBSERVED. AFTER REPLACEMENT OF THE DISPOSABLE COMPONENTS, VALUES CONSISTENT WITH ANESTHESIA WERE OBSERVED. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423684 ↗MalfunctionFeb 23, 2026High Readings
THE CUSTOMER REPORTED THAT THE SENSOR CONTINUES TO SHOW HIGH VALUE DURING ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24423455 ↗MalfunctionDec 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THE PATIENT REMAINED AWAKE WHILE THE PSI VALUES CONTINUOUSLY STAYED BETWEEN 18 AND 25. THE SENSOR WAS ATTACHED BEFORE INDUCTION, AND ALL IMPEDANCE INDICATORS WERE GREEN. EVEN THOUGH INDUCTION HAD NOT YET STARTED, THE PSI VALUE DROPPED FROM 100 TO 25. DURING THIS TIME, THE PATIENT'S EYES WERE OPEN. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723599 ↗MalfunctionMay 19, 2020Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE VALUE DID NOT DROP BELOW 50 DURING ANESTHESIA. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10071468 ↗MalfunctionMar 20, 2020High Readings; High Readings
THE CUSTOMER REPORTED THAT THE PATIENT STATE INDEX (PSI) DID NOT DROP BELOW 88. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9860061 ↗MalfunctionMar 14, 2020Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED PSI MEASUREMENTS WHICH WERE NOT IN THE EXPECTED RANGE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9832927 ↗MalfunctionMar 14, 2020Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE PATIENT STATE INDEX (PSI) WAS NOT IN THE EXPECTED RANGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9832858 ↗MalfunctionAug 16, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE PSI DETECTED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8902319 ↗MalfunctionAug 16, 2019High Readings; High Readings
THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED HIGH PSI VALUES. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8902117 ↗MalfunctionAug 15, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THE DEVICE PROVIDED INACCURATE PSI VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8897878 ↗MalfunctionAug 8, 2019High Readings; High Readings
THE CUSTOMER REPORTED HIGH PSI DETECTED, OVER 90. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8876430 ↗MalfunctionAug 1, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE PSI READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8851633 ↗MalfunctionAug 1, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE PSI VALUES. IT DID NOT GO DOWN UNDER 80. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8851624 ↗MalfunctionAug 1, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE PSI VALUES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8851622 ↗MalfunctionAug 1, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE PSI READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8851621 ↗MalfunctionAug 1, 2019Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED INACCURATE PSI READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8851620 ↗MalfunctionAug 1, 2019High Readings; High Readings
THE CUSTOMER REPORTED HIGH PSI READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8851616 ↗MalfunctionJul 25, 2019High Readings; High Readings
THE CUSTOMER REPORTED HIGH PSI MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8829090 ↗MalfunctionJul 22, 2019Low Readings; Low Readings
THE CUSTOMER REPORTED LOWER PSI VALUE THAN NORMAL RANGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8812552 ↗
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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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