Drive 15030BV-HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383211534), received between Oct 21, 2021 and Feb 16, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2023Overheating of Device; Material Deformation; Overheating of Device; Material Deformation

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING AN ELECTRIC BED, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE END USER OF THE BED STATED THAT "HE WAS INJURED AND DEVELOPED BREAKDOWN AND HAS AN OPEN WOUND ON HIS BACK" THE END USER DID NOT SEEK MEDICAL ATTENTION. DRIVE DID NOT RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Burn(s); Tissue Breakdown

  MAUDE report 16388739 ↗
• InjuryOct 21, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. THE UNIT WAS NOT RETURNED FOR EVALUATION. WE WILL SUBMIT A FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE HAD A CRACK IN THE FOOTBOARD. THE USER HAS DIABETES AND CUT HER LEG ON THE FOOT BOARD. THE DEVICE IS ALSO LEANING ON THE LEFT SIDE. WHILE ASLEEP THE USER FELL OUT AND FRACTURED HER HIP. SHE HAS HAD MEDICAL ATTENTION. SHE IS IN A HYPO CHAMBER FOR THE LACERATION DUE TO THE DIABETES.

  Patient problems: Hip Fracture; Laceration(s)

  MAUDE report 12678163 ↗