Drive 15201BVRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00822383143026), received between Dec 7, 2020 and Oct 10, 2024 — classified as 2 deaths, 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Use of Device Problem; Use of Device Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BED BY THE PROVIDER WHO REPORTED THE BEDRAIL "POPPED OFF" AND THE END USER FELL OUT OF THE BED DURING PERSONAL CARE. THE END USER WAS ADMITTED TO THE HOSPITAL WITH FRACTURES TO THEIR FEMUR AND TIBIA BONES AND LACERATIONS TO BOTH LEGS THAT REQUIRED SKIN GRAFTS. BASED ON OUR INVESTIGATION, IT APPEARS THAT THE CUSTOMER USED A BED RAIL THAT WAS INCOMPATIBLE WITH THE BED. 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: Laceration(s); Limb Fracture

  MAUDE report 20421759 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BED HALF RAIL BY A PROVIDER WHO REPORTED THAT THE HALF RAIL CAME OFF THE BED WHEN CAREGIVERS WERE TURNING THE PATIENT, CAUSING THEM TO FALL OFF THE BED AND BREAK THEIR COLLAR BONE, REQUIRING HOSPITAL TREATMENT. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING CONFIRMING THE SKU OF THE HALF RAIL INVOLVED IN THE INCIDENT, SINCE THE SKU ORIGINALLY REPORTED IS DIFFERENT THAN THE HALF RAIL THAT WAS RETURNED TO DRIVE FOR EVALUATION. IN ADDITION, SINCE THE RETURNED RAIL WAS OBSERVED TO BE INTACT AND UNBROKEN, DRIVE IS GATHERING FURTHER INFORMATION REGARDING HOW THE HALF RAIL WAS ATTACHED TO THE BED. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18230790 ↗
• DeathMar 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  FROM DRIVE DEVILBISS: DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED RAIL. THE INCIDENT WAS REPORTED TO CPSC. WE ARE FILING THIS REPORT PRIOR TO COMPLETION OF OUR INVESTIGATION.. THE REPORT WILL BE AMENDED WHEN ADDITIONAL INFORMATION IS ACQUIRED. THE END-USER WAS IN HOSPICE CARE. HIS EQUIPMENT WAS CHANGED WITHIN THE LAST TWO (2) WEEKS OF HIS LIFE INCLUDING HIS BED RAIL, LOW AIR LOSS MATTRESS AND HOSPITAL BED. THE FACILITY WAS INDEPENDENT LIVING, ADVANCED CARE HOME. HE WAS PLACED ON A TWO(2) HOUR WATCH SINCE HE HAD BEEN TRYING TO EXIT THE BED TO GET A DRINK. A CARE WORKER FOUND HIM TRAPPED UNDER THE BED RAIL WITH HIS FEET RESTING ON THE GROUND. HE DIED OF ACCIDENTAL, MECHANICAL ASPHYXIATION. THE NURSE ON STAFF THAT EVENING IS NO LONGER AN EMPLOYEE OF THE HOSPICE AND IS THEREFORE UNAVAILABLE FOR COMMENT. THE HOSPITAL SUPERVISOR REPORTED THAT THE DEVICES WERE RETURNED TO THE SERVICE PROVIDER AFTER THE INCIDENT. SHE ADVISED THAT THERE WERE NO ISSUES OR CONCERNS WITH THE RAILS, MATTRESSES, AND HOSPITAL BED. THERE WAS NO INVESTIGATION OF THE PRODUCTS AT THE HOSPICE LEVEL, DRIVE HAS UNABLE TO INDEPENDENTLY VERIFY THE CONFIGURATION OF THE PRODUCTS SINCE THE

  Patient problems: Physical Entrapment

  MAUDE report 13649139 ↗
• DeathJun 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED RAIL. THE INCIDENT WAS REPORTED TO (B)(6). WE ARE FILING THIS REPORT PRIOR TO COMPLETION OF OUR INVESTIGATION.THE REPORT WILL BE AMENDED WHEN ADDITIONAL INFORMATION IS ACQUIRED. THE END-USER WAS IN HOSPICE CARE. HIS EQUIPMENT WAS CHANGED WITHIN THE LAST TWO (2) WEEKS OF HIS LIFE INCLUDING HIS BED RAIL, LOW AIR LOSS MATTRESS AND HOSPITAL BED. THE FACILITY WAS INDEPENDENT LIVING, ADVANCED CARE HOME. HE WAS PLACED ON A TWO(2) HOUR WATCH SINCE HE HAD BEEN TRYING TO EXIT THE BED TO GET A DRINK. A CARE WORKER FOUND HIM TRAPPED UNDER THE BED RAIL WITH HIS FEET RESTING ON THE GROUND. HE DIED OF ACCIDENTAL, MECHANICAL ASPHYXIATION. THE NURSE ON STAFF THAT EVENING IS NO LONGER AN EMPLOYEE OF THE HOSPICE AND IS THEREFORE UNAVAILABLE FOR COMMENT. THE HOSPITAL SUPERVISOR REPORTED THAT THE DEVICES WERE RETURNED TO THE SERVICE PROVIDER AFTER THE INCIDENT. SHE ADVISED THAT THERE WERE NO ISSUES OR CONCERNS WITH THE RAILS, MATTRESSES, AND HOSPITAL BED. THERE WAS NO INVESTIGATION OF THE PRODUCTS AT THE HOSPICE LEVEL, DRIVE HAS UNABLE TO INDEPENDENTLY VERIFY THE CONFIGURATION OF THE PRODUCTS SINCE THEY WERE DISASSEMBLED AND RETURNED TO THE PR

  Patient problems: Physical Entrapment

  MAUDE report 11935305 ↗
• InjuryDec 7, 2020Unintended Movement; Unintended Movement

  (B)(6) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. WE WILL FILE AN UPDATED REPORT WHEN WE EVALUATE THE DEVICE. THIS REPORT IS IN RESPONSE TO MEDWATCH FILING 101545-2020-16. END-USER WAS TRYING TO GET INTO BED. SHE GRABBED THE RIGHT SIDE RAIL ON THE BED. SHE REPORTED THAT THE RAIL BECAME SHAKY. SHE LOST HER BALANCE, FELL AND HIT HER HEAD. SHE COMPLAINED OF PAIN IN SACRAL AND COCCYX AREA. THE RAIL MAY HAVE DETACHED FROM THE BED; HOWEVER, THIS HAS NOT BEEN CONFIRMED. IT IS UNKNOWN WHETHER A PRODUCT DEFECT OR USER ERROR/LACK OF MAINTENANCE LED TO THE INCIDENT. X-RAYS CONFIRMED A FRACTURED PELVIS.

  Patient problems: Fall; Pain

  MAUDE report 10958401 ↗