Citadel Plus FX811B3B4AMABBRecalls & reported problems

Summary

The FDA's MAUDE database contains 358 adverse event reports that list this exact device (DI 05055982756532), received between Jun 26, 2017 and Sep 30, 2026 — classified as 2 deaths, 19 injuries, 337 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (267 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 25 most recent of 358 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Detachment of Device or Device Component

  Arjo was informed about an event involving a Citadel Plus bed. The customer reported that a side rail had malfunctioned. No patient was involved, and no injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943070 ↗
• MalfunctionSep 28, 2026Detachment of Device or Device Component

  At the time of collection of the Citadel Plus bed frame from the customer, the Arjo service technician observed that the left-hand foot-end side rail was detached from the bed frame (the lower arm had been pulled out at one attachment point). Photographic evidence provided confirmed the malfunction. No patient was involved and no injuries were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911740 ↗
• MalfunctionSep 17, 2026Detachment of Device or Device Component

  The customer reported that the Citadel Plus bed is damaged.The Arjo service technician inspected the bed and found that the right-hand foot-end side rail detached. The screws holding the panel to the metal plate were ripped off. Moreover, parts of the side rail assembly were affected, the upper arms were disconnected from the side rail panel, the lower arm was cracked, pivot pins were bent and bearing plates broken. The photographic evidence provided confirmed malfunctions. There was no indication of the patient involvement. No injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50800816 ↗
• MalfunctionSep 3, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50584001 ↗
• DeathAug 12, 2026Use of Device Problem

  Based on the collected information, a patient on comfort care, was experiencing difficulty breathing, and low blood pressure after caregivers rolled the patient to change the bed sheets. Caregivers positioned the Citadel Plus bed in reverse Trendelenburg to boost the patient's breathing. After doing so, the bed made a loud noise and then all the lights started to blink. The bed remained locked in reverse Trendelenburg. According to the information provided, the patient became apneic, and pulseless, and subsequently passed away. At this time, no additional clinical details have been provided regarding the cause of death. There was no allegation that the bed caused or contributed to the patient's death.The bed was inspected by Arjo service technician. No malfunction was found.

  Patient problems: Apnea; Dysphasia; Low Blood Pressure/ Hypotension

  MAUDE report 50218916 ↗
• MalfunctionJul 3, 2026Use of Device Problem; Material Twisted/Bent

  ARJO BECAME AWARE THAT THE SIDE RAIL BROKE WHEN THE PATIENT FELL OFF THE CITADEL PLUS BED FRAME WHILE EXITING THE BED OVER NIGHT. NO INJURY WAS SUSTAINED. THE ARJO SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE LEFT-HAND FOOT-END SIDE RAIL REMAINED ATTACHED TO THE FRAME BUT WAS SEVERELY BENT AND DENTED. ADDITIONALLY, BOTH THE EXTENSION FRAME AND THE BED FRAME WERE ALSO BENT.

  Patient problems: Fall

  MAUDE report 25700738 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component

  ARJO BECAME AWARE OF THE CITADEL PLUS BED FRAME MALFUNCTION. THE DEVICE INSPECTION CONDUCTED BY ARJO SERVICE TECHNICIAN REVEALED THAT THE UPPER ARMS (PARTS OF THE SIDE RAIL ASSEMBLY) WERE DISCONNECTED FROM THE SIDE RAIL PANEL. MOREOVER, ONE OF THE THREADED PLATES THAT STRENGTHENS THE SIDE PANEL (SIDE RAIL) SHIFTED TOGETHER WITH THE SCREWS HOLDING THE PLASTIC MOLDING. PHOTOGRAPHIC EVIDENCE PROVIDED CONFIRMED THE MALFUNCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25357748 ↗
• MalfunctionMay 28, 2026Use of Device Problem; Insufficient Device Problem Information

  ARJO BECAME AWARE THAT THE PATIENT FELL OFF THE CITADEL PLUS BED FRAME. ACCORDING TO THE NURSE, THE SIDE RAILS WERE BROKEN. NO INJURIES WERE REPORTED. THE BED WAS INSPECTED BY AN ARJO SERVICE TECHNICIAN, NO DEVICE MALFUNCTION WAS FOUND, SIDE RAIL OPERATED AS INTENDED.

  Patient problems: Fall

  MAUDE report 25315737 ↗
• MalfunctionMay 26, 2026Unintended Movement

  THE NURSE REPORTED THAT WHILE THE PATIENT WAS RESTING IN THE BED, THE HEAD SECTION OF THE BED UNEXPECTEDLY ELEVATED TO ITS MAXIMUM POSITION WITHOUT ANY APPARENT USER INPUT. FOLLOWING THIS EVENT, HEALTHCARE STAFF WERE UNABLE TO LOWER THE HEAD SECTION USING THE STANDARD BED CONTROLS. THE ISSUE COULD ONLY BE RESOLVED BY DISCONNECTING THE BED FROM THE POWER SUPPLY AND USING THE HANDHELD REMOTE CONTROL TO RETURN THE HEAD SECTION TO A LOWER POSITION. AT THE TIME OF THE EVENT, THE BED WAS OCCUPIED BY A PATIENT. NO INJURY WAS REPORTED. THE DEVICE INSPECTION CONDUCTED BY ARJO SERVICE TECHNICIAN REVEALED THAT ONE OF THE SIDE RAILS WAS DAMAGED, THE TAPE (SEAL) BETWEEN THE SIDE RAIL PANEL AND THE SIDE RAIL MECHANISM WAS PULLING OFF. ANOTHER SIDE RAIL HAD BROKEN BEARING PLATES. THE TECHNICIAN WAS NOT ABLE TO RECREATE ALLEGED UNINTENDED MOVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25274555 ↗
• InjuryMay 18, 2026Detachment of Device or Device Component

  THE ARJO REPAIR TECHNICIAN WAS INFORMED BY THE CUSTOMER STAFF ABOUT AN INCIDENT INVOLVING A CITADEL PLUS BED FRAME. IT WAS REPORTED THAT THE PATIENT FELL FROM THE BED AND WAS INJURED WHEN THE SIDE RAIL BROKE. THE INCIDENT OCCURRED WHILE THE CUSTOMER STAFF WAS BATHING THE PATIENT, WHO WAS LEANING AGAINST THE RIGHT SIDE RAIL AT THAT TIME. INITIALLY, THERE WAS NO INDICATION THAT ANY MEDICAL INTERVENTION WAS REQUIRED. ON 21 APRIL 2026, ARJO RECEIVED NEW INFORMATION RELATED TO THIS EVENT. THE CLAIM ALLEGES THAT THE PATIENT FALL ASSOCIATED WITH THE HOSPITAL BED RESULTED IN A FEMUR FRACTURE REQUIRING HOSPITALISATION AND MEDICAL TREATMENT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 25200024 ↗
• MalfunctionMay 15, 2026Detachment of Device or Device Component

  DURING THE PICK-UP OF THE BED FROM THE CUSTOMER, AN ARJO SERVICE TECHNICIAN NOTICED THAT THE LEFT-HAND FOOT-END SIDE RAIL HAD DETACHED. THE SCREWS SECURING THE PANEL TO THE METAL PLATE HAD BEEN PULLED OUT. THERE WAS NO CUSTOMER ALLEGATION. NO INJURY WAS REPORTED, AND THERE WAS NO INDICATION OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180328 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT UPON WAKING FROM SURGERY, THE PATIENT BECAME AGITATED AND WAS BANGING, PUSHING, AND PULLING ON THE SIDE RAIL, WHICH RESULTED IN ITS DETACHMENT FROM THE CITADEL PLUS BED FRAME. NO INJURY WAS REPORTED. INSPECTION CONDUCTED BY ARJO SERVICE TECHNICIAN REVEALED THAT SCREWS HOLDING THE PANEL TO THE METAL PLATE WERE RIPPED OFF. PHOTOGRAPHIC EVIDENCE PROVIDED CONFIRMED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25168587 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component

  ARJO BECAME AWARE OF THE CITADEL PLUS BED FRAME MALFUNCTION. THE CUSTOMER REPORTED: "LEFT RAILING IS BROKEN. VERY LOOSE. SAFETY ISSUE." NO INJURY WAS REPORTED. THE ARJO SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE LEFT-HAND FOOT-END SIDE RAIL DETACHED. THE SCREWS HOLDING THE PANEL TO THE METAL PLATE WERE RIPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157279 ↗
• MalfunctionMay 7, 2026

  ADMIT: [REDACTED]-ADMISSION DAY ZERO AT 0141. [REDACTED]-DAY 2 WOUND CARE ORDERED A CITADEL PLUS ATMOS AIR. [REDACTED]-DAY 5 ARJO WAS NOTIFIED ON BED NOT BEING FUNCTIONAL AND IS GOING TO GET SWAPPED OUT.. [REDACTED]-DAY 11 ARJO REPLACED SIDERAIL OF THE LEFT FOOT DUE TO DAMAGE. [REDACTED]-DAY 31 THE PATIENT WAS DISCHARGED. [REDACTED]-4 DAYS OF [REDACTED]-LAST YEAR, THEN AGAIN FROM [REDACTED-REDACTED]-6 DAYS IN THE ATTACHMENT, IT STATES: [REDACTED] SCREWS STILL ATTACHED BUT BARELY HANGING ON, INSERTS WERE PULLED FROM PLASTIC [REDACTED] PANEL PARTIAL DETACHMENT FROM THE BED, AND THE ISSUE MAY RESULT IS PATIENT FALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111327 ↗
• MalfunctionMay 4, 2026Detachment of Device or Device Component

  DURING THE PICK-UP OF THE CITADEL PLUS BED FRAME FROM THE CUSTOMER, IT WAS FOUND THAT THE LEFT-HAND FOOT-END SIDE RAIL DETACHED FROM THE BED FRAME, THE SCREWS SECURING THE PANEL TO THE METAL PLATE WERE RIPPED OUT. ADDITIONALLY, THE RIGHT-HAND FOOT-END SIDE RAIL WAS DAMAGED, THE TAPE (SEAL) BETWEEN THE SIDE RAIL PANEL AND THE SIDE RAIL MECHANISM WAS PULLING OFF. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067424 ↗
• MalfunctionApr 30, 2026Unintended Movement

  THE CUSTOMER REPORTED THAT THE CITADEL PLUS BED FRAME CONTINUED TO ELEVATE, INDICATING POTENTIAL UNINTENDED MOVEMENT. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURY WAS REPORTED. AN ARJO SERVICE TECHNICIAN INSPECTED THE BED, AND NO MALFUNCTION WAS FOUND. THE BED WAS SUBSEQUENTLY RENTED TO ANOTHER CUSTOMER, AND NO FURTHER COMPLAINTS WERE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25041097 ↗
• MalfunctionApr 17, 2026Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE SIDE RAIL OF THE CITADEL PLUS BED FRAME WAS BROKEN AND HANGING OFF. THE ARJO SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE LEFT-HAND FOOT-END SIDE RAIL HAD DETACHED. THE LOWER ARM OF THE SIDE RAIL ASSEMBLY HAD DISCONNECTED FROM THE PANEL. ADDITIONALLY, ONE OF THE THREADED PLATES RESPONSIBLE FOR STRENGTHENING THE SIDE RAIL WAS PARTIALLY TORN OFF TOGETHER WITH THE 2 SCREWS SECURING THE PLASTIC MOULDING. PHOTOGRAPHIC EVIDENCE PROVIDED CONFIRMED THE MALFUNCTIONS. THE PATIENT WAS ON THE BED AT THE TIME. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910157 ↗
• MalfunctionApr 8, 2026Unintended Movement

  THE BED WAS LOWERING BY ITSELF. NO PATIENT INVOLVEMENT. NO INJURY WAS CLAIMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813985 ↗
• MalfunctionApr 8, 2026Use of Device Problem; Insufficient Device Problem Information

  ARJO BECAME AWARE THAT THE PATIENT FELL OUT OF THE CITADEL PLUS BED FRAME. NO INJURY WAS REPORTED.

  Patient problems: Fall

  MAUDE report 24813301 ↗
• MalfunctionApr 3, 2026Unintended Movement

  ARJO WAS NOTIFIED THAT THE CITADEL PLUS BED FRAME MOVED DOWN UNINTENTIONALLY. THERE WAS NO INDICATION OF THE PATIENT INVOLVEMENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780995 ↗
• MalfunctionApr 2, 2026Unintended Movement

  DURING THE QUALITY CONTROL CHECK PERFORMED AT THE ARJO SERVICE CENTRE, IT WAS NOTED THAT THE CITADEL PLUS BED FRAME MOVED UNINTENTIONALLY BECAUSE THE BUTTON RESPONSIBLE FOR THE DOWNWARD MOVEMENT, LOCATED ON THE ATTENDANT CONTROL PANEL ON THE RIGHT-HAND HEAD-END SIDE RAIL, WAS STUCK IN THE ACTIVATED POSITION. THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762908 ↗
• MalfunctionMar 20, 2026Use of Device Problem; Material Twisted/Bent

  ARJO BECAME AWARE OF AN EVENT INVOLVING A CITADEL PLUS BED FRAME. THE CUSTOMER REPORTED THAT A 430-LB PATIENT IN A STATE OF DELIRIUM ATTEMPTED TO EXIT THE BED BY CLIMBING OVER THE SIDE RAIL, DESPITE BEING UNABLE TO WALK. THE SIDE RAIL BROKE, AND THE PATIENT FELL FROM THE BED ONTO THE FLOOR. AN ARJO SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE RIGHT-HAND FOOT-END SIDE RAIL WAS BENT BUT STILL ATTACHED TO THE FRAME. NO INJURIES WERE REPORTED.

  Patient problems: Fall

  MAUDE report 24647385 ↗
• MalfunctionMar 17, 2026Detachment of Device or Device Component

  DURING THE QUALITY CONTROL INSPECTION OF THE CITADEL PLUS BED FRAME UPON ITS RETURN FROM THE CUSTOMER, IT WAS FOUND THAT TWO OF THE FOUR SCREWS HOLDING THE PANEL TO THE METAL PLATE STARTED TO PULLING OUT. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614566 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  ARJO BECAME AWARE OF THE CITADEL PLUS BED FRAME MALFUNCTION. THE NURSING STAFF REPORTED THAT THE BED IS BROKEN AND NEEDS TO BE REPLACED. THE DEVICE INSPECTION REVEALED THAT THE LOWER ARM THAT IS A PART OF THE SIDE RAIL ASSEMBLY WAS BROKEN IN TWO PIECES CAUSING PARTIAL SIDE RAIL DETACHMENT. IT WAS CONFIRMED BY THE PHOTOGRAPHIC EVIDENCE PROVIDED. THERE WAS NO INDICATION OF THE PATIENT INVOLVEMENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596595 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  AT THE TIME OF THE PICKUP OF THE CITADEL PLUS BED FRAME FROM THE CUSTOMER, THE ARJO REPRESENTATIVE FOUND THAT THE LEFT-HAND FOOT-END SIDE RAIL WAS PARTIALLY DETACHED. TWO OUT OF THE FOUR SCREWS HOLDING THE PANEL TO THE METAL PLATE HAD BEEN RIPPED OUT AND THE UPPER ARM PIVOT PIN (PART OF THE SIDE RAIL ASSEMBLY) WAS BENT. MOREOVER, THE RIGHT-HAND FOOT-END SIDE RAIL WAS BENT. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566667 ↗