Drive 15300BV-PKGRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383212319), received between May 7, 2019 and Jun 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJun 15, 2023Break; Break

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BARIATRIC HOSPITAL BED BY AN END USER'S PARTNER, WHO REPORTED THAT THE FRAME WAS "BROKEN" AND THE END USER " FELL OFF THE BED AND HURT HER BACK AND BOTTOM." HE DID NOT SPECIFY ANY MEDICAL TREATMENT SHE RECEIVED. 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 17139878 ↗
• MalfunctionMay 7, 2019Material Integrity Problem; Material Integrity Problem

  (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A BED. THE WELD BROKE AND THE FRAME CAME LOOSE FROM THE HEADBOARD. THE BED SLID INTO THE WALL CAUSING THE OCCUPANT TO HIT HER HEAD. THE HEADBOARD THEN FEEL FORWARD ON TOP OF HER. INCIDENT EXACERBATED HER RHEUMATOID ARTHRITIS. PATIENT HAS HEAT APPLIED TO HER BACK BEFORE SLEEP.

  Patient problems: Bruise/Contusion; Pain

  MAUDE report 8588159 ↗