Arial 59360Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840948100642), received between Jun 28, 2024 and Jun 28, 2024 — classified as 1 injury.

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.

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

  RA RESPONDED TO A CALL FROM THE RESIDENT FOUND BETWEEN BED AND BATH. SHE SAID THAT SHE HIT HER HEAD AND WAS TRANSFERRED TO THE HOSPITAL. STAFF DID RESPOND TO PENDANT PUSH AROUND 7:30 PM. AFTER LAST MED PASS AT 10:00 PM AFTER THE NURSE WALKED OUT RESIDENT STATED THAT THEY PUSHED PENDANT AT THAT TIME AND IT SHOWS THAT PENDANT WAS PUSHED BUT RESETTING WITHIN ONE MINUTE. RESIDENT DID GO TO ER AND IS HAVING BACK ISSUES. SHE STATED THAT THEY DID NOT RECEIVE ANY PAGES FOR THE ALARM.

  Patient problems: Head Injury

  MAUDE report 19634065 ↗