Arial 54336Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840948100666), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 28, 2024Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  CALL LIGHT WAS TURNED ON AT 12:45:12 AND TURNED ITSELF OFF AT 12:45:15. AT 12:47:35 WE CAN SEE ON THE CAMERAS THAT THE RESIDENT IS ON THE FLOOR SCOOTING OUT OF HER ROOM. CALL LIGHT TURNS ITSELF BACK ON AT 12:48:13. NOBODY ELSE WENT IN THE ROOM BEFORE THIS. STAFF TURNS IT OFF AT 12:50:10. DOME LIGHT WAS VISIBLE IN CAMERA VIEW AND CONFIRMED ALL OF THIS INFORMATION.

  Patient problems: Head Injury

  MAUDE report 19634151 ↗