Neptune E-SEP 0703-120-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327297805), received between Dec 10, 2018 and Dec 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Temperature Problem” (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

Recent adverse event reports

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

• MalfunctionDec 10, 2018Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE, THE USER PUT THE DEVICE ON TOP OF THE DRAPE AND THE DRAPE STARTED TO BURN. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS, NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8147942 ↗