Natus 016862Recalls & reported problems
Xltek · Natus Quantum II Base Unit · Class 2
All models of Natus (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00382830047265), received between Nov 28, 2022 and Jul 13, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrostatic Discharge” (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.
Most reported problems
Device problems
- Electrostatic Discharge1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2023Electrostatic Discharge; Electrostatic Discharge
PART 016862R NATUS QUANTUM II BASE UNIT REFURBISHED - 2 PATIENTS SAID THEY COULD FEEL SOMETHING WHEN THE ELECTRODES WERE APPLIED AND THE STUDY WAS RUNNING. THE FIRST PATIENT DESCRIBED THE FEELING AS BEING COLD, THE SECOND PATIENT DESCRIBED IT AS STATIC FEELING SHE COULD FEEL ALL OVER HER BODY. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314466 ↗MalfunctionNov 28, 2022Sparking; Sparking
PART 016862 NATUS BASE UNIT - DISTRICT SALES MANAGER REPORTS UNIT DEFECTIVE, THERE ARE SPARKS WHEN PLUGGING A BREAKOUT BOX INTO IT. CUSTOMER PROVIDED VIDEO. FOLLOW UP EMAILS SENT TO TECHNICAL SUPPORT FOR 3RD REQUEST FOR ADVERSE EVENT QUESTIONNAIRE AND 2ND REQUEST FOR ALLEGED DEFECTIVE ITEM BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15874745 ↗
Other Full-Montage Standard Electroencephalograph devices
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- Seer Home SM-03-8001-INTSeer 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 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 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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