Enterprise 9814DF101BCUSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05055982755207), received between Jul 15, 2020 and Feb 3, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Use of Device Problem

  ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE ENTERPRISE 9000X BED. THE CUSTOMER REPORTED THAT THE BED ALARM WAS NOT WORKING, AND THE PATIENT FELL FROM THE BED. NO INJURY WAS SUSTAINED.

  Patient problems: Fall

  MAUDE report 24243925 ↗
• MalfunctionNov 5, 2025Unintended Movement; Unintended Movement

  ARJO WAS INFORMED ABOUT AN EVENT INVOLVING THE ENTERPRISE 9000X BED. THE CUSTOMER REPORTED THAT THE BED WAS MOVING ON ITS OWN, STATING THAT THE ENTIRE BED WAS GOING UP AND DOWN WITHOUT ANY COMMAND. THE PATIENT WAS IN BED, AND NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475296 ↗
• MalfunctionMay 6, 2025Fracture; Fracture

  CUSTOMER REPORTED THAT BACKREST OF THE ENTERPRISE 9000X BED WOULD NOT GO UP OR DOWN. AT THE TIME, BED WAS USED BY A PATIENT. NO INJURY WAS REPORTED. ARJO TECHNICIAN VISITED THE SITE TO INSPECT THE DEVICE. UPON INSPECTION, IT WAS FOUND THAT THE MID-SECTION OF THE BED FRAME WAS BENT. ADDITIONALLY, THE GAS SPRING AND BACKREST HINGE WERE BROKEN. THE BACKREST SECTION WAS DETACHED ON THE LEFT SIDE, CAUSING THE BED FRAME TO TILT TO THE LEFT. THIS TILT PREVENTED THE LEFT HEAD SIDE RAIL FROM BEING LOCKED IN THE RAISED POSITION. PHOTOGRAPHIC EVIDENCE OF DAMAGES WAS PROVIDED. DUE TO BENT MID-FRAME, THE BED IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966009 ↗
• InjuryMar 17, 2025Use of Device Problem; Use of Device Problem

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING AN ENTERPRISE 9000X BED. IT WAS REPORTED THAT A BED EXIT ALARM DID NOT WORK PROPERLY, AND THE PATIENT FELL FROM THE BED. AS A RESULT OF THE FALL, THE PATIENT BROKE THEIR HIP.

  Patient problems: Fall; Hip Fracture

  MAUDE report 21617263 ↗
• InjuryMar 17, 2025Use of Device Problem; Use of Device Problem

  ARJO WAS NOTIFIED OF AN EVENT INVOLVING AN ENTERPRISE 9000X BED. IT WAS REPORTED THAT A BED EXIT ALARM DID NOT WORK PROPERLY, AND THE PATIENT FELL FROM THE BED. AS A RESULT OF THE FALL, THE PATIENT BROKE THEIR HIP.

  Patient problems: Fall; Hip Fracture

  MAUDE report 21617260 ↗
• MalfunctionOct 18, 2024Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION GATHERED, THERE WAS AN INDICATION OF AN UNINTENDED MOVEMENT ON THE ENTERPRISE 9000X BED. IT WAS REPORTED THAT THE BED BACKREST WAS RAISING ON ITS OWN. THERE WAS NO INDICATION THAT THE BED WAS USED WITH A PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479867 ↗
• MalfunctionAug 27, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE ENTERPRISE 9000X BED WAS STUCK IN THE TRENDELENBURG POSITION WITH A PATIENT. IT WAS INDICATED THAT THERE WAS NO POWER IN THE SIDE RAIL. THE PATIENT WAS SAFELY REMOVED FROM THE BED AND PLACED IN A CHAIR. NO INJURIES WERE REPORTED. THE BED WAS SWAPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074000 ↗
• InjuryJul 15, 2020Unintended Movement; Unintended Movement

  FOLLOWING INFORMATION REPORTED, THE ENTERPRISE 9000X BED PLATFORM LOWERED UNINTENDED, WHEN THE RIGHT SIDE FOOT-END SIDE RAIL, WHICH WAS PLACED IN THE LOWERED POSITION, WAS GENTLY MOVED BY A CAREGIVER. NO PATIENT INVOLVEMENT AND NO INJURY WAS REPORTED TO ARJO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275336 ↗