Citadel CX611B3F4AMAB0Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05056097342184), received between Dec 21, 2023 and Aug 7, 2025 — classified as 2 deaths, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Use of Device Problem; Use of Device Problem

  ARJO BECAME AWARE OF THE EVENT INVOLVING THE CITADEL BED FRAME. THE FACILITY REPORTED A PATIENT FELL OUT OF BED DURING A TURNING MANEUVER. ALLEGEDLY THE LEFT SIDE RAIL APPEARED TO BE BROKEN, BECAME UNLOCKED AND WENT DOWN. NO INJURY WAS SUSTAINED. THE ARJO SERVICE TECHNICIAN INSPECTED THE DEVICE AND FOUND NO MALFUNCTION IN THE SIDE RAIL LOCKING MECHANISM.

  Patient problems: Fall

  MAUDE report 22737326 ↗
• MalfunctionFeb 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS CLAIMED BY A CUSTOMER THAT THE SAFETY SIDES WERE BROKEN AND HAD ELECTRICAL PROBLEMS. THERE WAS NO INDICATION REGARDING THE PATIENT INVOLVEMENT. NO INJURY WAS CLAIMED. IT WAS ESTABLISHED THAT ONE OF THE SAFETY SIDES WAS DETACHED FROM THE FRAME, AND THE SCREWS ATTACHING THE PANEL TO THE FRAME WERE PARTIALLY RIPPED OFF. THE SECOND REPLACED SAFETY SIDE HAD AN ELECTRICAL PROBLEM- THE ISSUE IS NOT CONSIDERED SAFETY-RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467769 ↗
• InjuryFeb 18, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS CLAIMED BY CUSTOMER THAT THE MATTRESS WAS NOT FILLING IN THE CENTER AND THE PATIENT'S PRESSURE SORE WORSENED. THE PATIENT SUSTAINED A SERIOUS INJURY (LEFT HIP BUTTOCKS INJURY)THE DEVICE WAS SWAPPED OUT. DURING THE EVALUATION WAS FOUND THAT THE AIRBOX MALFUNCTIONED. THE COMPRESSOR LEAKAGE WAS IDENTIFIED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21397296 ↗
• InjuryFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS CLAIMED BY CUSTOMER THAT THE MATTRESS WAS NOT FILLING IN THE CENTER AND THE PATIENT'S PRESSURE SORE WORSENED. THE PATIENT SUSTAINED A SERIOUS INJURY (LEFT HIP BUTTOCKS INJURY) THE DEVICE WAS SWAPPED OUT. DURING THE EVALUATION WAS FOUND THAT THE AIRBOX MALFUNCTIONED. THE COMPRESSOR LEAKAGE WAS IDENTIFIED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21393328 ↗
• DeathOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS CLAIMED BY A CUSTOMER THAT THE PATIENT FELL WHILE TRYING TO GRAB THE SAFETY SIDE. THE NURSE WAS CLEANING THE PATIENT AND WHEN SHE ROLLED THE PATIENT TO THE OTHER SIDE, THE PATIENT ROLLED OFF THE BED. ALLEGEDLY THE SAFETY SIDE WAS NOT WORKING AS CORRECTLY AND IT FELL WHEN THE PATIENT WAS TRYING TO REACH IT. THE PATIENT CODED AND EXPIRED WITHIN MINUTES FROM THE INCIDENT. THE ARJO FIELD SERVICE ENGINEER INSPECTED THE DEVICE ON-SITE AND FOUND NO ISSUE WITH THE BED. ALL SAFETY SIDE WERE FUNCTIONING AS INTENDED. IT WAS FOUND ONLY THE FOOTBOARD MISSING.

  Patient problems: Fall

  MAUDE report 20516982 ↗
• DeathOct 23, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS CLAIMED BY A CUSTOMER THAT THE PATIENT FELL WHILE TRYING TO GRAB THE SAFETY SIDE. THE NURSE WAS CLEANING THE PATIENT AND WHEN SHE ROLLED THE PATIENT TO THE OTHER SIDE, THE PATIENT ROLLED OFF THE BED. ALLEGEDLY THE SAFETY SIDE WAS NOT WORKING AS CORRECTLY AND IT FELL WHEN THE PATIENT WAS TRYING TO REACH IT. THE PATIENT CODED AND EXPIRED WITHIN MINUTES FROM THE INCIDENT. THE ARJO FIELD SERVICE ENGINEER INSPECTED THE DEVICE ON-SITE AND FOUND NO ISSUE WITH THE BED. ALL SAFETY SIDE WERE FUNCTIONING AS INTENDED. IT WAS FOUND ONLY THE FOOTBOARD MISSING.

  Patient problems: Fall

  MAUDE report 20516226 ↗
• MalfunctionAug 27, 2024Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION GATHERED, THERE WAS AN INDICATION OF AN UNINTENDED MOVEMENT ON THE CITADEL BED. IT WAS REPORTED THAT THE BACKREST WAS ELEVATING ON ITS OWN WITHOUT ANY BUTTONS BEING PRESSED. THE BED EVALUATION REVEALED THAT THE CONTROL BUTTON ON THE SAFETY SIDE RAIL WAS STUCK. THE FAULTY SIDE RAIL WAS REPLACED WHICH SOLVED THE ISSUE. THERE WAS NO INDICATION THAT THE BED WAS USED BY A PATIENT DURING THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20074965 ↗
• MalfunctionApr 26, 2024Unintended Movement; Unintended Movement

  FOLLOWING THE INFORMATION GATHERED, THE BED PLATFORM LOWERED WITHOUT ACTIVATION ANY BUTTONS ON CONTROL PANEL. THE EVENT WAS OBSERVED IN ARJO SERVICE CENTER. THE TECHNICIAN DURING QUALITY CHECK FOUND STUCKED CONTROL PANEL BUTTON. THE SAFETY SIDE WAS REPLACED AND THE BED STARTED TO OPERATE CORRECTLY. NO ALLEGATION FROM THE CUSTOMER SITE WAS CLAIMED. THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS CLAIMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190059 ↗
• MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SIDE RAIL WAS DETACHED FROM THE CITADEL BED FRAME. THE BOTH UPPER ARMS THAT ARE PART OF THE SIDE RAIL ASSEMBLY WERE DISCONNECTED FROM THE BED. THERE WAS NO INDICATION THAT THE BED FRAME WAS IN USE WHEN THE ISSUE OCCURRED. NO INJURY WAS CLAIMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370730 ↗