Natus OBM00002Recalls & reported problems
Xltek · OBM Data Acquisition Box (DAB) · Class 2
All models of Natus (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382830010825), received between May 4, 2023 and Jan 11, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 7, 2025Open, Classified
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Z-1925-2025 · Root cause: Employee error · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Failure of Device to Self-Test1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) MISLABELED. THE CUSTOMER REPORTED EXPERIENCING ISSUES WITH THEIR OBM (OLYMPIC BRAINS MONITOR) HAVING THE ELECTRODE PLACEMENT STICKER ON BACKWARDS, RESULTING IN THE ELECTRODES BEING APPLIED INCORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18490690 ↗MalfunctionJun 12, 2023Failure of Device to Self-Test; Failure of Device to Self-Test
PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX) - OBM DAB (DIGITAL ACQUISITION BOX) - THE CUSTOMER REPORTED A SIGNAL, "FAILED SELF CHECK." PER QUESTIONNAIRE, THE MEDICAL TEAM WERE WORKING WITH A BABY WHEN THE OBM SIGNALED "FAILED SELF CHECK" FOR 20 -30 MINUTES. THE REGISTERED NURSE TRIED TO TROUBLESHOOT, INCLUDING CHANGING TO A DIFFERENT USB. THE OBM UNIT FINALLY WORKED AFTER 7-8 ATTEMPTS BUT THEY WERE UNCLEAR WHAT MADE THE DIFFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17112782 ↗MalfunctionMay 4, 2023No Display/Image; No Display/Image
PART OBM00002 OBM DAB (DIGITAL ACQUISITION BOX): NATUS OLYMPIC BRAINZ MONITOR WAS CONNECTED TO A PATIENT AND FUNCTIONING. SUDDENLY THE MONITOR STOPPED WORKING, STARTED BEEPING, AND THE MONITORING STOPPED. UNABLE TO RESUME MONITORING AFTER ALL CONNECTIONS WERE CHECKED, MONITOR TURNED OFF AND BACK ON. NO PATIENT OR USER HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16873181 ↗
Other Amplitude-Integrated Electroencephalograph devices
- Natus 022419Xltek · Amplitude-Integrated Electroencephalograph1 report
- Xltek 034879Xltek · Amplitude-Integrated Electroencephalograph1 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 · each recall links to the FDA recall notice
- 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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