Sedline 9829Recalls & reported problems
Masimo Corporation · Sedline Module · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843997012898), received between Jul 2, 2018 and Feb 18, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “High Readings” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- High Readings1
- Incorrect Measurement1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026High Readings
THE CUSTOMER REPORTED THAT DURING CARDIAC SURGERY, "THE ROOT/SEDLINE SYSTEM INDICATED INSUFFICIENT SEDATION FOR A PERIOD OF APPROXIMATELY 20 MINUTES. THE PATIENT WAS THEREFORE GIVEN DEEPER SEDATION. AFTER THIS PERIOD OF ANESTHESIA, THE DATA NO LONGER APPEARED TO BE PLAUSIBLE". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24374021 ↗MalfunctionJul 2, 2018Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE CLINICIAN'S IMPRESSION OF THE PATIENT'S STATE (MOVING) WAS NOT CONSISTENT WITH THE PATIENT STATE INDEX VALUES PROVIDED BY THE DEVICE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7656981 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.