Natus 515-019000Recalls & reported problems
Natus Neurology Incorporated · NicoletOne V32 Amplifier · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382830037167), received between Mar 7, 2018 and Mar 7, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Sense” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Failure to Sense1
- Unable to Obtain Readings1
Patient problems
- Misdiagnosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2018Unable to Obtain Readings; Failure to Sense; Unable to Obtain Readings; Failure to Sense
EEG BRAIN TEST; WAVES APPEARED FLAT, IN REALITY THEY WERE NOT FLAT.
Patient problems: Misdiagnosis
MAUDE report 7322136 ↗
Other Full-Montage Standard Electroencephalograph devices
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- NIM-ECLIPSE® ECLCMedtronic Xomed, Inc. · Full-montage Standard Electroencephalograph53 reports
- Seer Home Monitoring PortalSeer Medical Holdings Limited · Full-Montage Standard Electroencephalograph1 recall0 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
- 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 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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