Natus 10388Recalls & reported problems
Xltek · BRAIN MONITOR BASE WHITE · Class 2
- 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 00382830002523), received between Dec 8, 2022 and May 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component or Accessory Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Component or Accessory Incompatibility1
- Fire1
Patient problems
- Blister1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Fire
POWER CORD/PLUG FROM THE UPS CAUGHT FIRE. IT HAS SCORCH MARKS AND MELTING AROUND THE CORD. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157951 ↗MalfunctionDec 8, 2022Component or Accessory Incompatibility; Component or Accessory Incompatibility
PART 10388 BRAIN MONITOR BASE UNIT- CLIENT ADVISED THEY HAVE HAD PATIENTS WITH SKIN BREAKDOWN AFTER HAVING AN EXTENDED (24HR OR MORE) EEG STUDY. ACCORDING TO THE QUESTIONNAIRE RESPONSES, THE PATIENT HAD SMALL BLISTER, SCRAPES ON THE FOREHEAD AND BEHIND THE EARS, REQUIRING A WOUND CARE CONSULTATION. NUPREP AND ALCOHOL WERE USED TO CLEAN PATIENT SKIN PRIOR TO PROCEDURE. 10/20 CREAM WAS USED IN CONJUNCTION WITH THE ELECTRODES.
Patient problems: Blister
MAUDE report 15938518 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.