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neoBLUE blanket Large Pad KitRecalls & reported problems

Natus Medical Incorporated · neoBLUE blanket Large Pad Kit · 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 00382830015394), received between Sep 13, 2022 and Sep 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Dent in Material” (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

  • Dent in Material1
  • Material Frayed1

Patient problems

  • Skin Inflammation/ Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 13, 2022Material Frayed; Dent in Material; Material Frayed; Dent in Material

    THE NEOBLUE BLANKET WAS USED ON A PATIENT APPROX. 2 WEEKS AGO. IT WAS NOTICED THAT THE CHILD HAD PRESSURE DAMAGE OF THE SKIN BEHIND THE RIGHT EAR. THEY HAVE NOT INDICATED ANY FAULT TO US IN TERMS OF DAMAGE TO THE CHILD AS THE CHILD WAS QUITE OEDEMATOUS.

    Patient problems: Skin Inflammation/ Irritation

    MAUDE report 15414557 ↗

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Sources and updates

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