Drive 15561Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383963525), received between Jul 18, 2022 and Jul 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Installation-Related 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.

• InjuryJul 18, 2022Installation-Related Problem; Installation-Related Problem

  DRIVE DEVILBISS HEALTHCARE WAS CONTACTED REGARDING AN INCIDENT INVOLVING A PATIENT THAT FELL OFF OF A HOME HEALTHCARE BED. THE PATIENT'S SON REPORTED THAT HIS MOTHER ROLLED OFF OF THE BED ONTO THE FLOOR, HITTING HER HEAD AND SUSTAINING A LACERATION, AND WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT'S SON REPORTED THAT THE INCIDENT OCCURRED BECAUSE NEITHER HE NOR HIS MOTHER'S IN-HOME HEALTHCARE PROVIDERS WERE EVER ABLE TO ATTACH THE LEFT BED RAIL TO THE BEDFRAME. THE PATIENT'S SON REPORTED THAT THE RIGHT BED RAIL WAS IN USE, AND WAS UNABLE TO SPECIFY ANY DEFECT IN THE LEFT BED RAIL OR REASON THAT IT WAS UNABLE TO BE ATTACHED TO THE BED. IN ADDITION, THE PATIENT'S SON NEVER CONTACTED THE BED'S DISTRIBUTOR REGARDING THE INCIDENT, AND ONLY FIRST CONTACTED DRIVE DEVILBISS HEALTHCARE REGARDING THE INCIDENT APPROXIMATELY ONE YEAR AFTER IT OCCURRED, AND HAD DISCARDED THE BED AND RAIL. THEREFORE, DRIVE WAS UNABLE TO RETRIEVE OR EVALUATE THE PRODUCT. AT THE TIME OF THE INCIDENT, THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND WAS INITIALLY "LUCID AND RECOVERING FROM THE TRAUMA RESULTING FROM [THE] FAULTY BED RAIL," BUT WAS DIAGNOSED WITH COVID UPON ARRIVAL AT THE HOSPITAL, AND PASSED AWAY FRO

  Patient problems: Head Injury; Laceration(s)

  MAUDE report 15046602 ↗