Natus 019-400500Recalls & reported problems
Natus Neurology Incorporated · Disposable Ground Plate Electrode, 1.0m (39") lead, (1.5mm DIN), 1/pouch · 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 00382830041041), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Temperature Problem” (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
- Temperature Problem1
Patient problems
- Blister1
- 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.
MalfunctionJun 10, 2022Temperature Problem
NATUS RECEIVED NOTIFICATION OF A REPORT (MW5109076) RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM. GRD PLATE 1.0M LEAD 24 POCH/PK - CUSTOMER USED A DISPOSABLE GROUND PLATE ELECTRODE DURING QSART STUDY WHICH CAUSED A SMALL BLISTER 5 MILLIMETER BURN ON THE PATIENT'S FOREARM.
Patient problems: Blister; Burn(s)
MAUDE report 14652245 ↗
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- BIS 186-0200Covidien LP · Electrode, Cutaneous5 reports
- Rhythmlink® DC2415Rhythmlink International, LLC · Electrode, Cutaneous2 reports
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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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