Natus 016867Recalls & reported problems
Xltek · Natus Quantum II Breakout Main · Class 2
All models of Natus (13)
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 00382830047272), received between Jun 2, 2022 and Jun 2, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
- Loss of Data1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2022Loose or Intermittent Connection; Loss of Data; Loose or Intermittent Connection; Loss of Data
DEVICE - NATUS QUANTUM 64 - INTERNAL SOCKET FOR CABLE CONNECTION BECOMING LOOSE FROM CASING AND DATA LOSS FOLLOWING TEMPORARY DISCONNECTION OF PATIENT FROM MAIN MONITOR, ISSUES WITH RE-CONNECTION. THE REPORTER NOTED THAT THIS WAS NOT A PROBLEM WITH PREVIOUS VERSION OF THIS TECHNOLOGY. THE REPORT FURTHER NOTED THAT THE PATIENTS BEING MONITORED ARE PEOPLE WITH SEVERE EPILEPSY AND SEIZURE DATA HAS BEEN LOST ON A NUMBER OF OCCASIONS. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14572929 ↗
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- 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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