Embla 021920Recalls & reported problems
Xltek · NATUS EMBLA SDx · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382830047241), received between Jul 31, 2023 and Jul 31, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Fell” (3 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
Device problems
- Device Fell3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2023Device Fell; Device Fell
PART 021920 NATUS EMBLA SDX BREAKOUT - THE DOCTOR REPORTED THAT THE HEADBOX FELL ON A PATIENT'S HEAD BECAUSE THE RUBBER HANDLE CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17430785 ↗MalfunctionJul 31, 2023Device Fell; Device Fell
PART 021920 NATUS BRAIN MONITOR BREAKOUT - THE DOCTOR CONFIRMED THAT THE PATIENT MOVED, PULLED OUT THE WIRES, AND THE BREAKOUT BOX FELL ON HIM. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17430717 ↗MalfunctionJul 31, 2023Device Fell; Device Fell
PART 021920 NATUS BRAIN MONITOR BREAKOUT - THE DOCTOR CONFIRMED THAT THE PATIENT MOVED, PULLED OUT THE WIRES, AND THE BREAKOUT BOX FELL ON HIM. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17422888 ↗
Other Full-Montage Standard Electroencephalograph devices
- NA OPM660Medtronic Xomed, Inc. · Full-montage Standard Electroencephalograph101 reports
- NIM-ECLIPSE® ECLCMedtronic Xomed, Inc. · Full-montage Standard Electroencephalograph53 reports
- Seer Home SM-01-8001Seer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Seer Home SM-03-8001-INTSeer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Seer Home Monitoring PortalSeer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 reports
- Sedline® Seditation Monitor 9513Masimo Corporation · Full-montage Standard Electroencephalograph38 reports
- NA DAQ916Medtronic Xomed, Inc. · Full-montage Standard Electroencephalograph27 reports
- SedLine™ EEG Sensor 2479Masimo Corporation · Full-montage Standard Electroencephalograph14 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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