Citadel CX811A3F3AMAB0Recalls & reported problems
Arjohuntleigh AB · Medical Bed - CX811A3F3AMAB0 - USA WITH OUT · Class 2
All models of Citadel (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arjo Citadel bed is a powered flotation therapy bed. Many of the 125 reports describe the bed moving on its own, patients falling from it, or side rails and buttons coming loose or failing. The reports include 1 death and 15 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 125
- Deaths reported
- 1
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 05055982755764), received between May 23, 2018 and Sep 21, 2026 — classified as 1 death, 15 injuries, 109 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (36 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement36
- Use of Device Problem32
- Detachment of Device or Device Component30
- Insufficient Device Problem Information9
- Adverse Event Without Identified Device or Use Problem5
- Sparking5
- Mechanical Problem4
- Activation Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- Fall37
- No Consequences Or Impact To Patient12
- No Patient Involvement4
- Ulcer4
- Bruise/Contusion3
- Convulsion/Seizure3
- Hematoma2
Recent adverse event reports
The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Use of Device Problem
According to the information provided by the customer, the patient fell from the bed and the patient was not aware of what was going on. The customer also indicated that a side rail was down and that the VariZone patient movement/exit detection system did not generate an alarm. No injury was reported.Technical evaluation of the bed was performed. The customer-reported alarm failure could not be reproduced. Functional testing confirmed that the side rails and the VariZone patient movement/exit detection system operated as intended, and no device malfunction that could have contributed to the reported fall was identified. Upon delivery of the replacement bed, the service representative provided instructions regarding the proper use of the bed sensory alarm.
Patient problems: Fall
MAUDE report 50835218 ↗MalfunctionSep 10, 2026Unintended Movement
At the time of the inspection of the Citadel bed frame returned from the customer, an Arjo service technician found that the button responsible for the backrest upward movement, located on the attendant control panel (ACP) on the right-hand foot-end side rail, was stuck in the activated position. There was no patient involvement, and no injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50708357 ↗MalfunctionAug 14, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50248101 ↗InjuryJul 29, 2026Failure to Run on Battery
The patient experienced a seizure, followed by respiratory arrest and the Citadel bed did not perform as intended for a code blue. It was stated the battery died and the patient had an emergency intubation and was transferred to ICU. According to the Arjo Clinical Specilist the patient's intubation and transfer to ICU does meet the definition of a serious injury.Additionally, as a result of this event, the caregiver had to support the patient's position to maintain the patient's airway, which caused the caregiver to injure their back. However, there was no indication that the caregiver's back injury was serious.
Patient problems: Convulsion/Seizure; Respiratory Arrest
MAUDE report 50065932 ↗InjuryJul 29, 2026Failure to Run on Battery
The patient experienced a seizure, followed by respiratory arrest and the Citadel bed did not perform as intended for a code blue. It was stated the battery died and the patient had an emergency intubation and was transferred to ICU. According to the Arjo Clinical Specilist the patient's intubation and transfer to ICU does meet the definition of a serious injury.Additionally, as a result of this event, the caregiver had to support the patient's position to maintain the patient's airway, which caused the caregiver to injure their back. However, there was no indication that the caregiver's back injury was serious.
Patient problems: Convulsion/Seizure; Respiratory Arrest
MAUDE report 50065929 ↗MalfunctionJun 25, 2026Unintended Movement
DURING A QUALITY CONTROL INSPECTION PERFORMED AFTER THE CITADEL BED FRAME WAS RETURNED FROM THE CUSTOMER, AN ARJO SERVICE TECHNICIAN OBSERVED THAT THE BED MOVED INTO THE CHAIR POSITION WITHOUT ANY COMMAND BEING GIVEN. THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS REPORTED. THE LEFT-HAND HEAD-END SAFETY SIDE HAD A DEFECTIVE AUTO-CHAIR BUTTON ON THE CONTROL PANEL. THE ISSUE WAS RESOLVED BY REPLACING THE SIDE RAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25618966 ↗MalfunctionJun 3, 2026Use of Device Problem
ARJO BECAME AWARE THAT THE PATIENT FELL FROM THE CITADEL BED TWICE. NO INJURIES WERE SUSTAINED. REPORT 3007420694-2026-00095 RELATES TO THE FIRST FALL, WHILE REPORT RELATES TO THE SECOND FALL. MOREOVER, THE BIOMED REPRESENTATIVE INFORMED THAT THE BED EXIT ALARM OR NURSE CALL SYSTEM WAS DEFECTIVE. THE DEVICE INSPECTION DID NOT REVEAL ANY MALFUNCTIONS.
Patient problems: Fall
MAUDE report 25371619 ↗MalfunctionMay 26, 2026Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE LEFT-HAND FOOT-END SIDE RAIL OF THE CITADEL BED IS TOTALLY DETACHED. THE ARJO SERVICE TECHNICIAN INSPECTED THE BED AND FOUND THAT THE SCREWS HOLDING THE PANEL TO THE METAL PLATE WERE RIPPED OFF. THE BED WAS LIKELY BEING USED BY A PATIENT. NO INJURY WAS CLAIMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276522 ↗MalfunctionMay 12, 2026Detachment of Device or Device Component
ARJO BECAME AWARE OF THE CITADEL BED FRAME MALFUNCTION. THE CUSTOMER REPORTED THAT THE "HEAD OF BED WON'T RAISE DUE TO A BROKEN PIECE." THE BED WAS IN USE BY A PATIENT WHEN THE ISSUE OCCURRED. NO INJURY WAS REPORTED. AN INSPECTION CARRIED OUT BY AN ARJO REPRESENTATIVE REVEALED THAT THE SCREW SECURING THE HINGE TO THE FRAME WAS MISSING. THIS FAILURE RESULTED IN THE HINGE DISCONNECTION. ADDITIONALLY, THE BACKREST DAMPER AND THE BACKREST ACTUATOR WERE DAMAGED AND REQUIRED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25146453 ↗MalfunctionMay 12, 2026Unintended Movement
ARJO BECAME AWARE THAT THE CITADEL PATIENT CARE SYSTEM WAS NOT FUNCTIONING PROPERLY. THE CUSTOMER REPORTED: "FOOT SECTION OF THE BED NOT INFLATING, BUTTONS ARE NOT ON". THE BED WAS IN USE BY A PATIENT AT THE TIME. NO INJURY WAS REPORTED. NO SYSTEM MALFUNCTION WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25146452 ↗MalfunctionApr 17, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED. NO INJURY WAS SUSTAINED. THE CIRCUMSTANCES OF THE EVENT REMAINED UNKNOWN. THE NURSE CLAIMED THAT AN "EXIT ALARM" WAS ON, BUT DID NOT SOUND AT THE NURSE STATION. IT WAS IDENTIFIED THAT THE NURSE CALL CABLE WAS NOT PROPERLY ATTACHED TO THE HOSPITAL SYSTEM. THE STAFF IS RESPONSIBLE FOR THE CORRECT CONNECTION OF THE NURSE CALL CABLE.
Patient problems: Fall
MAUDE report 24907899 ↗MalfunctionMar 31, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED. NO INJURY WAS SUSTAINED. THE CUSTOMER INDICATED THAT THE PATIENT WAS TRYING TO GET OUT OF BED. NO INJURY WAS SUSTAINED. THE STAFF CLAIMED THAT AT THE TIME OF THE FALL, THE VARIZONE MOVEMENT SYSTEM WAS ON AND DID NOT SOUND. THE BED WAS SWAPPED TO THE SERVICE CENTER. THE BED EVALUATION WAS PERFORMED, AND THE PATIENT'S MOVEMENT SYSTEM WAS CHECKED; NO MALFUNCTION WAS FOUND.
Patient problems: Fall
MAUDE report 24738966 ↗MalfunctionMar 31, 2026Detachment of Device or Device Component
THE SAFETY SIDE DETACHED FROM THE FRAME. THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS CLAIMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24738965 ↗MalfunctionMar 31, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED. NO INJURY WAS SUSTAINED. THE CUSTOMER INDICATED THAT THE PATIENT WAS TRYING TO GET OUT OF BED. NO INJURY WAS SUSTAINED. THE STAFF CLAIMED THAT AT THE TIME OF THE FALL, THE VARIZONE MOVEMENT SYSTEM WAS ON AND DID NOT SOUND. THE BED WAS SWAPPED TO THE SERVICE CENTER. THE BED EVALUATION WAS PERFORMED, AND THE PATIENT'S MOVEMENT SYSTEM WAS CHECKED; NO MALFUNCTION WAS FOUND.
Patient problems: Fall
MAUDE report 24738949 ↗MalfunctionFeb 4, 2026Sparking
DURING PLUG IN THE BED INTO THE SOCKET, THE BED SPARKED. THERE WAS NO INDICATION OF THE PATIENT'S INVOLVEMENT. NO INJURY WAS CLAIMED. THE ARJO REPRESENTATIVE REPLACED THE POWER CORD, AND THE BED WAS OPERATED AS INTENDED. NO VISUAL SIGNS OF THE POWER CABLE DAMAGES WAS OBSERVED BY THE ARJO REPRESENTATIVE. HOWEVER, TAKING A CONSERVATIVE APPROACH, HE DECIDED TO REPLACE THE BEDS POWER CORD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256053 ↗MalfunctionJan 29, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT FELL OUT OF BED. A MINOR HEAD LACERATION WAS SUSTAINED. NO MEDICAL INTERVENTION WAS REQUIRED. THE INJURY WAS ASSESSED BY A CLINICAL SPECIALIST AS A NON-SERIOUS INJURY. THE ALLEGATION THAT THE NURSE CLAIMED WAS AN EXIT ALARM MALFUNCTION. THE BED EXIT ALARM (VARIZONE MOVEMENT SYSTEM) WAS NOT WORKING PROPERLY. THE TECHNICIAN DECIDED TO RESET THE BED BY PULLING ALL OF THE CABLES INCLUDING THE MAIN POWER TO THE CU20 CONTROLLER, AND THEN UNPLUGGED THE BED FROM THE MAIN POWER WAITED ABOUT THIRTY SECONDS, AND PLUGGED IT BACK IN.
Patient problems: Fall; Laceration(s)
MAUDE report 24208569 ↗MalfunctionJan 23, 2026Unintended Movement
THE CUSTOMER CLAIMED THAT THE BED WAS GOING UP ON ITS OWN. THERE WAS NO INDICATION REGARDING PATIENT INVOLVEMENT. NO INJURY WAS CLAIMED. THE BED WAS SWAPPED AND THE DEVICE TESTING WAS PERFORMED. THE SERVICE CENTER DID NOT FIND ANY ISSUE WITH THE BED. THE ALLEGED SCENARIO WAS NOT DUPLICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24159323 ↗MalfunctionDec 12, 2025Unintended Movement; Unintended Movement
DURING THE DEVICE EVALUATION AT THE ARJO SERVICE CENTER, IT WAS FOUND THAT THE LEFT HEAD SIDERAIL HAD A FAULTY DOWN BUTTON AT THE CONTROL PANEL AND THAT THE BED LOWERED DOWN BY ITSELF. THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS SUSTAINED. THE ALLEGED BUTTON WAS EXPOSED AND DAMAGED PHYSICALLY. THE FAULTY SIDE RAIL WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23787369 ↗MalfunctionDec 9, 2025Unintended Movement; Unintended Movement
THE BED WAS FOUND TO BE MOVING UNINTENTIONALLY AT ARJO SERVICE CENTER. THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS CLAIMED. THE BED WAS RENTED BY A CUSTOMER AND WAS REPLACED DUE TO AN ERROR CODE THAT COULD NOT BE CLEARED. THERE WAS NO ALLEGATION THAT THE BED MOVED UNINTENTIONALLY IN ANY DIRECTION. THE DEVICE WAS EVALUATED AND AN E300 ERROR CODE WAS FOUND, INDICATING THAT THE BUTTON REMAINED IN THE ACTIVATED POSITION FOR MORE THAN 90 SECONDS. THE ENGINEER REPAIRED THE DEVICE BY REPLACING BOTH HEAD SAFETY SIDES AND THE ACTUATOR RESPONSIBLE FOR THE UP/DOWN MOVEMENT. AFTER THE REPAIR, THE BED OPERATED CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23754353 ↗MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE BED PICK-UP THE ARJO REPRESENTATIVE FOUND THE BED RIGHT BODY SAFETY SIDE COMPLETELY RIPPED OFF. THERE WAS NO INDICATION THAT THE BED WAS USED FOR TREATMENT AT THAT TIME. NO INJURY WAS SUSTAINED. THE ARJO REPRESENTATIVE DURING THE BED PICK-UP FOUND THAT THE SAFETY SIDE MOUNTING SCREWS WERE COMPLETELY RIPPED OFF RESULTING IN PANEL DETACHMENT FROM THE FRAME. THE DEVICE WAS SWAPPED, AND THE BED WAS REPAIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23656007 ↗MalfunctionNov 26, 2025Unintended Movement; Unintended Movement
THE NURSE STATED THE BED WAS RISING BY ITSELF, AND THE BED SHOWED THE ERROR CODE E300. THERE WAS NO INDICATION OF THE PATIENT'S INVOLVEMENT. NO INJURY WAS CLAIMED. THE BED WAS SWAPPED FOR FURTHER EVALUATION AT THE ARJO SERVICE CENTER. THE BED EVALUATION IDENTIFIED THE ISSUE WITH THE STUCKED UP - BUTTON ON THE ATTENDANT CONTROL PANEL LOCATED ON THE RIGHT HEAD SAFETY SIDE. THE WHOLE SAFETY SIDE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23655997 ↗MalfunctionNov 12, 2025Unintended Movement; Unintended Movement
THE CUSTOMER CLAIMED THAT THE BED WAS LOCKED; HOWEVER STILL IT WAS STILL RISING ON ITS OWN. THERE WAS NO INDICATION REGARDING THE PATIENT'S INVOLVEMENT. NO INJURY WAS SUSTAINED. THE DEVICE WAS SWAPPED, AND IT WAS FOUND THAT THE NURSE CONTROL PANEL LOCATED ON THE RIGHT-SIDE PANEL HAD A DEFECTIVE UP BUTTON. THE BUTTON RESPONSIBLE FOR MOVING THE BED UP WAS STUCK IN THE ACTIVATED POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23531525 ↗MalfunctionNov 5, 2025Use of Device Problem; Use of Device Problem
ARJO WAS NOTIFIED OF AN EVENT INVOLVING A CITADEL BED, IN WHICH A PATIENT REPORTEDLY FELL FROM THE BED. THE PATIENT SUSTAINED BRUISES, AND NO FURTHER ATTENTION WAS NEEDED. THE REASON WHY THE PATIENT EXITED THE BED REMAINS UNKNOWN. THE PATIENT WAS FOUND ON THE FLOOR BY A NURSE, AND THE SAFETY SIDES WERE RAISED WHEN THE NURSE ATTENDED TO THE PATIENT. IT WAS NOTED THAT THE BED EXIT ALARM DID NOT ACTIVATE. THE DEVICE WAS THOROUGHLY INSPECTED AT THE ARJO SERVICE CENTER, AND BED EXIT ALARMS WERE TESTED AT ALL SENSITIVITY SETTINGS. NO ISSUE WITH THE ALARM WAS IDENTIFIED. ADDITIONALLY, AT THE SERVICE CENTER, IT WAS DISCOVERED THAT THE LEFT BODY SIDE RAIL WAS DAMAGED, THE COVER AND TAPE WERE UNGLUED, AND THE SCREWS WERE LOOSE BUT STILL INSERTED. DESPITE THOSE DAMAGES, THE SAFETY SIDE WAS STILL ABLE TO BE SECURELY RAISED OR LOWERED. THE SIDE RAIL WAS REPLACED.
Patient problems: Bruise/Contusion; Fall
MAUDE report 23473773 ↗MalfunctionOct 30, 2025Use of Device Problem; Use of Device Problem
IT WAS CLAIMED THAT THE PATIENT LEANED ON THE SIDE RAIL, CAUSING IT TO BREAK. THE PATIENT FELL OUT OF THE BED. NO INJURY WAS SUSTAINED. ACCORDING TO THE NURSE'S STATEMENT, "THE PATIENT WAS PUSHING ON THE SIDE RAIL TRYING TO GET OUT, AND THE LOCKING MECHANISM FAILED AFTER THE PATIENT PUSHED ALL THEIR WEIGHT ONTO IT." THE SAFETY SIDE WAS RAISED AT THE TIME OF THE EVENT. THE BED WAS SWAPPED OUT. NO DEVICE MALFUNCTION WAS FOUND AT THE SERVICE CENTER.
Patient problems: Fall
MAUDE report 23423015 ↗MalfunctionAug 6, 2025Use of Device Problem; Use of Device Problem
ARJO WAS INFORMED ABOUT A PATIENT¿S FALL FROM A CITADEL BED. IT WAS REPORTED THAT THE SIDE RAIL WAS NOT RAISED AND LATCHED, AND THE PATIENT ROLLED OVER AND FELL OUT OF THE BED. A NURSE STATED THAT THE PATIENT WAS IMMOBILE AND COULD NOT UNDERSTAND HOW THE FALL OCCURRED. NO INJURIES WERE REPORTED.
Patient problems: Fall
MAUDE report 22724624 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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