Drive RTL1493COMRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822383246192), received between Dec 23, 2021 and May 13, 2022 — classified as 3 deaths.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathMay 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MARCH 24, 2022, DRIVE DEVILBISS HEALTHCARE WAS FIRST NOTIFIED VIA SERVICE OF A LEGAL COMPLAINT OF AN INCIDENT THAT OCCURRED ON (B)(6) 2020 INVOLVING THE BED ASSIST HANDLE, WHICH IS SUBJECT TO A VOLUNTARY RECALL IN COOPERATION WITH THE CPSC IMPLEMENTED IN DECEMBER 2021. THE COMPLAINT ALLEGES WRONGFUL DEATH AS A RESULT OF THE END USER'S USE OF THE BED ASSIST HANDLE. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT AND WILL FILE AN UPDATE IF AND WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DRIVE ENCOURAGES CONSUMERS WHO HAVE THE RECALLED BED HANDLES TO CONTACT DRIVE TO PARTICIPATE IN THE VOLUNTARY RECALL AND RECEIVE A REFUND. PLEASE VISIT WWW.RECALLRTR.COM/BEDHANDLES, OR DRIVE'S WEBSITE AT WWW.DRIVEMEDICAL.COM (CLICK ON "IMPORTANT SAFETY INFORMATION" AT THE TOP OF THE PAGE), OR CALL (877) 467-3099 FROM 8:00 A.M. TO 7:00 P.M. ET, MONDAY THROUGH FRIDAY.

  Patient problems: Insufficient Information

  MAUDE report 14395738 ↗
• DeathJan 12, 2022Entrapment of Device; Entrapment of Device

  ON JANUARY 3, 2022, (B)(6) HEALTHCARE WAS FIRST NOTIFIED OF AN ENTRAPMENT INCIDENT THAT OCCURRED IN LATE (B)(6) OR EARLY (B)(6) 2018 INVOLVING THE BED ASSIST HANDLE, WHICH IS SUBJECT TO A VOLUNTARY RECALL IN COOPERATION WITH THE CPSC. THE END USER'S DAUGHTER WAS NOTIFIED OF THE RECALL IN (B)(6) 2021, AND CONTACTED THE COMPANY TO REPORT THE 2018 INCIDENT. ACCORDING TO THE REPORT, THE END USER, WHO WAS A RESIDENT IN HOSPICE CARE, BECAME ENTRAPPED AND WAS BRUISED "ALL OVER ON HIS ARM AND BACK." HE WAS FOUND BY A NURSE AND TRANSPORTED TO THE HOSPITAL. IT IS UNKNOWN HOW LONG HE WAS IN THE HOSPITAL, BUT IT WAS REPORTED THAT HE DIED ON (B)(6) 2018, WHICH WAS 2 TO 3 DAYS AFTER RETURNING FROM THE HOSPITAL. ACCORDING TO THE REPORT, HE DIED DUE TO "HEALTH COMPLICATIONS" AND/OR "PNEUMONIA." THE REPORTER INDICATED THAT THE BED ASSIST HANDLE AT ISSUE WAS DISCARDED IN 2018, SO THE COMPANY CANNOT INSPECT IT. HOWEVER, (B)(6) IS CURRENTLY INVESTIGATING THE INCIDENT AND WILL FILE AN UPDATE IF AND WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(6) ENCOURAGES CONSUMERS WHO HAVE THE RECALLED BED HANDLES TO CONTACT (B)(6) TO PARTICIPATE IN THE VOLUNTARY RECALL AND RECEIVE A REFUND. PLEASE VISIT (B)(6)

  Patient problems: Physical Entrapment

  MAUDE report 13240037 ↗
• DeathDec 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON DECEMBER 17, 2021, DRIVE RECEIVED A REPORT THAT IN (B)(6) 2016, AN END-USER OF THE SUBJECT BED HANDLE DIED AS A RESULT OF BECOMING ENTRAPPED BETWEEN THE HANDLE AND THE MATTRESS OF HIS BED. DRIVE DID NOT RECEIVE ANY FURTHER INFORMATION IN THE REPORT, AND IS CURRENTLY INVESTIGATING. THE BED HANDLE IS THE SUBJECT OF A VOLUNTARY RECALL THAT WAS ANNOUNCED BY THE CPSC AND HEALTH (B)(4) ON (B)(6) 2021. THE CPSC RECALL ANNOUNCEMENT IS ATTACHED. DRIVE WILL UPDATE THIS REPORT IF AND WHEN FURTHER INFORMATION BECOMES AVAILABLE.

  Patient problems: Physical Entrapment

  MAUDE report 13083065 ↗