Keypoint 9031E0722Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382830050449), received between Sep 24, 2019 and Sep 24, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K944547); they may or may not involve this specific model.

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

Recent adverse event reports

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

• MalfunctionSep 24, 2019Overheating of Device; Overheating of Device

  DEVICE WAS OMITTING A VERY STRONG BURNING SMELL. THERE WAS NO VISUAL SIGNS OF BURNING, NO SIGNS OF SMOKE DAMAGE OR MELTING ON THE STIM DEVICE. THIS ISSUE WAS FIRST NOTICED WHILE THE DEVICE WAS IN USE WITH A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K944547. One submission often covers many models, so check the product and lot details in each record.

• Z-1407-2013 · Apr 9, 2013 · Terminated
  Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9