BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PLUS

    MDR report key: 23347119 · Received October 21, 2025

    Report

    Report Number
    3007420694-2025-00266
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    UDI-DI
    05055982756754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE CITADEL PLUS INSTRUCTION FOR USE (IFU 831.374 REV.14) THERE ARE SEVERAL MENTIONS THAT WARN USER ABOUT POSSIBLE RISK OF PATIENT¿S FALL: ¿TO MINIMIZE RISK OF FALLS OR INJURY, THE BED SHOULD ALWAYS BE IN THE LOWEST PRACTICAL POSITION WHEN THE PATIENT IS UNATTENDED.¿ ¿CAREGIVER SHOULD ALWAYS AID PATIENT IN EXITING THE BED.¿ IN ADDITION, IFU INFORMING THE USERS HOW THE AES SYSTEM IS FUNCTIONING: "THE ANTI-ENTRAPMENT SYSTEM IS DESIGNED TO DETECT PATIENT ENTRAPMENT BETWEEN THE BASE AND DECK WHEN THE DECK IS LOWERED, OR IS PLACED INTO TILT OR AUTO-CHAIR. THE SYSTEM IS PERMANENTLY ACTIVE AND CANNOT BE SWITCHED OFF. IF THE BEAM IS INTERRUPTED (EXAMPLE: BY A PATIENTS LIMB) WHILE THE DECK IS LOWERING, THE DECK STOPS MOVING, LIFTS SLIGHTLY TO ALLOW THE OBSTRUCTION TO BE CLEARED, AND THE WEIGHING SYSTEM DISPLAY READS AES." ARJO DEVICE DID NOT FAIL IT SPECIFICATION, AS NO DEVICE MALFUNCTION WAS FOUND. THE DEVICE WAS USED FOR THE PATIENT TREATMENT AND FROM THAT PERSPECTIVE IT PLAYED THE ROLE IN THE EVENT. THE COMPLAINT WAS ASSESSED AS REPORTABLE DUE TO THE PATIENT'S FALL FROM THE BED. NO INJURY WAS SUSTAINED. THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER CLAIMED THAT THE PATIENT FELL OUT OF THE BED WHILE TRYING TO GET UP FROM THE DEVICE. NO INJURY WAS SUSTAINED AS A RESULT OF THE FALL. THE CUSTOMER STATED THAT THE BED WAS TOO HIGH AND THE PATIENT WAS NOT ABLE TO GET UP. THE ANTIENTRAPMENT SYSTEM (AES) CODE WAS LUMINATING ON THE DEVICE. THE TECHNICIAN FOUND THE OBSTRUCTION ON THE WAY OF THE AES, IT WAS REMOVED AND THE BED WENT BACK TO THE NORMAL OPERATION. NO DEVICE MALFUNCTION WAS IDENTIFIED, AND THE SYSTEM WAS FUNCTIONING CORRECTLY AS INTENDED. THE CUSTOMER STATED THAT THE BED WAS TOO HIGH, AND THEY COULD NOT ADJUST THE BED HEIGHT DUE TO THE AES CODE TRIGGERING WHILE ATTEMPTING TO LOWER THE BED. THE PATIENT WAS NOT ABLE TO GET UP INDEPENDENTLY. THE STAFF WAS ASSISTING THE PATIENT WHILE GETTING UP, HOWEVER THE PATIENT FELL OUT OFF THE BED PLATFORM. THE TECHNICIAN FOUND THE OBSTRUCTION ON THE WAY OF THE AES, IT WAS REMOVED AND THE BED WENT BACK TO THE NORMAL OPERATION. NO DEVICE MALFUNCTION WAS IDENTIFIED, AND THE SYSTEM WAS FUNCTIONING CORRECTLY AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841538 CITADEL PLUS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. FXX21A4D4AKBBB 05055982756754

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other