Natus 515-016200Recalls & reported problems
Natus Neurology Incorporated · EDX 8 channel Amplifier 0162 · Class 2
Data updated Oct 16, 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 00382830037303), received between Apr 26, 2024 and Apr 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
EDX 8 CHANNEL AMPLIFIER 0162 - PATIENT WAS UNDER GOING A COCHLEAR IMPLANT SURGERY AND AT THE END OF THE SURGERY THE SURGEON REPORTED THERE WAS A BURN AT THE SITE OF THE CHANNEL 2 ELECTRODES.
Patient problems: Burn(s)
MAUDE report 19193731 ↗
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- NA 8225490Medtronic Xomed, Inc. · Electromyograph, diagnostic1 report
- PULSE 50120104Nuvasive, Inc. · Electromyograph, diagnostic1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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