Drive 15021BVRecalls & reported problems
Drive Devilbiss Healthcare · BedsRails Product Description: Half Rail,T-Style,BrownVein,1pr/cs · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383143361), received between Oct 22, 2021 and Mar 8, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Device Damaged Prior to Use1
- Material Twisted/Bent1
Patient problems
- Bruise/Contusion1
- Eye Injury1
- Fall1
- Hip Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2024Material Twisted/Bent; Material Twisted/Bent
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BED RAIL BY A PATIENT, WHO REPORTED THAT AS HE USED THE RAIL TO ASSIST WITH STANDING UP, THE BAR BENT AND HE FELL TO THE FLOOR, BREAKING HIS HIP AND SUSTAINING OTHER BRUISES. DRIVE DEVILBISS HEALTHCARE IS IN THE PROCESS OF FACILITATING THE RETURN OF THE PRODUCT FOR INSPECTION AND WILL UPDATE THIS REPORT SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.
Patient problems: Bruise/Contusion; Hip Fracture
MAUDE report 18870238 ↗InjuryOct 22, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
(B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A HOSPITAL BED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE WILL BE FILING A FOLLOW-UP WHEN ADDITIONAL INFORMATION IS AVAILABLE. WE ARE SUBMITTING THIS REPORT IN AN OVERABUNDANCE OF CAUTION AND TO BE TIMELY. THE END-USER IS NONVERBAL. WHILE UNDER CAREGIVER SUPERVISION THE OCCUPANT FELL OUT OF THE DEVICE. SHE LANDED FACE DOWN AND HIT HER EYE. SHE SUSTAINED A BUMP ON HER EYE. THEY WERE WAITING FOR THE DOCTOR TO DO AN X RAY AND MAKE SURE EVERYTHING WAS OK. A FOLLOW-UP VISIT IS EXPECTED FROM THE DOCTOR. THE CAREGIVER BELIEVES THAT A PIECE, A SCREW, IS MISSING OFF THE RAIL ON ONE SIDE OF THE DEVICE. SHE IS UNAWARE OF WHEN THIS PIECE BECAME MISSING. SHE IS SEEKING REIMBURSEMENT FOR THE REPAIRS OF THE UNIT AND A TECHNICIAN COMING.
Patient problems: Eye Injury; Fall
MAUDE report 12685423 ↗
Other BED, MANUAL devices
- Drive 15201BVDrive Devilbiss Healthcare · BED, MANUAL2 deaths5 reports
- MedSurg Manual Bed FL23PUmano Medical Inc · Bed, Manual4 reports
- Drive 1222PDrive Devilbiss Healthcare · BED, MANUAL1 death1 report
- Drive 16500BVDrive Devilbiss Healthcare · BED, MANUAL1 report
- SleepSafe Manual Hi-Lo ComboSleepsafe Beds, LLC · Bed, Manual1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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