Drive 1222PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383543451), received between Jun 24, 2024 and Jun 24, 2024 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• DeathJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED ON AN INCIDENT INVOLVING A BED RAIL BY A PROVIDER WHO REPORTED THAT THE END USER COLLAPSED AGAINST THE BED PUSHING THE MATTRESS TO CREATE A SPACE BETWEEN THE MATTRESS AND BED RAIL AND TRAPPED THE END USER. THE NURSE WAS ABLE TO FREE THE END USER'S HEAD AND CONFIRM THAT THE END USER WAS STILL BREATHING. EMS ARRIVED TO TRANSPORT THE END USER TO THE HOSPITAL, BUT THE END USER EXPIRED ON THE WAY TO THE AMBULANCE. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 19601809 ↗