Drive 12011KD-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00822383224916), received between Feb 10, 2022 and Feb 21, 2024 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2024Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A TRANSFER BENCH BY A PROVIDER, WHO REPORTED THAT THE SEAT STARTED TO COLLAPSE AND CAUSED PRESSURE ON THE END USER'S LEG, RESULTING IN A BLISTER THAT REQUIRED AN ANTIBIOTIC FOR TREATMENT. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Blister

  MAUDE report 18748663 ↗
• InjuryJan 12, 2024Material Integrity Problem; Material Integrity Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A TRANSFER BENCH BY THE END USER'S SPOUSE, WHO REPORTED THAT THE FRONT LEG OF THE DEVICE COLLAPSED WHILE IN USE. THE END USER IS AN AMPUTEE THAT RECENTLY HAD SURGERY ON HIS STUMP. HE REPORTEDLY FELL ONTO HIS STUMP AND DEVELOPED A STAPHYLOCOCCUS/PSEUDOMONAS INFECTION THAT WAS TREATED WITH ANTIBIOTICS. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Skin Infection

  MAUDE report 18504192 ↗
• MalfunctionJun 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A BATH BENCH BY AN END USER'S DAUGHTER, WHO STATED THAT HER FATHER "FELL OFF THE CHAIR AND HIT HIS HEAD." THERE WERE NO ADDITIONAL DETAILS AS TO THE NATURE OF THE INJURY OR PRODUCT MALFUNCTION. THERE WAS NO REPORT OR EVIDENCE OF MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. 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: Fall; Head Injury

  MAUDE report 17167197 ↗
• MalfunctionJun 16, 2023Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BATH BENCH BY AN END USER, WHO STATED THAT ONE OF THE LEGS OF THE UNIT "BROKE," AND SHE REPORTEDLY "FELL FORWARD." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. 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: Fall

  MAUDE report 17148210 ↗
• MalfunctionApr 7, 2023Device Slipped; Device Slipped

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A CANE BY AN END USER, WHO STATED THAT "WHILE WALKING WITH THE CANE IT GOT WET AND HE SLIPPED AND FELL." THE END USER HIT HIS HEAD BUT DID NOT SEEK MEDICAL ATTENTION. 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: Fall

  MAUDE report 16699645 ↗
• InjuryMar 6, 2023Fracture; Fracture

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A TRANSFER BENCH BY AN END USER'S BROTHER, WHO STATED THAT "HIS BROTHER WAS USING THE TRANSFER BENCH AND THE LEG BROKE, CAUSING HIM TO FALL." HE WAS TRANSPORTED TO THE HOSPITAL FOR INJURED HIPS, KNEES AND A SORE ON HIS FOOT. HE IS CURRENTLY BACK AT HIS ASSISTED LIVING RESIDENCE AND IS RECEIVING THERAPY. 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: Fall; Limb Pain

  MAUDE report 16486529 ↗
• InjuryMar 6, 2023Device Slipped; Device Slipped

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A CANE BY AN END USER, WHO STATED THAT "WHILE WALKING WITH THE CANE IT GOT WET AND HE SLIPPED AND FELL." THE END USER HIT HIS HEAD BUT DID NOT SEEK MEDICAL ATTENTION. 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: Fall

  MAUDE report 16485683 ↗
• DeathDec 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A TRANSFER BENCH BY AN END USER, WHO STATED THAT HE SUSTAINED "BLEEDING AND INJURY" WHILE TRANSFERRING OUT OF HIS TUB. 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: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 15995352 ↗
• InjuryFeb 10, 2022Material Fragmentation; Material Fragmentation

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT WITH A BATH BENCH ON (B)(6). THE END-USER STATED THAT THE LEG OF HER BATH BENCH BROKE WHILE IN USE CAUSING HER TO FALL AND HIT HER HEAD. SHE "CALLED THE AMBULANCE TO ASSIST HER OUT OF THE TUB AND THEN TAKE HER TO THE HOSPITAL AND THEY SAID A DOCTOR WILL COME TO HER HOME SINCE THE HOSPITAL WAS FULL." SHE HAS NOT RETURNED THE UNIT. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Fall

  MAUDE report 13510613 ↗