BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PLUS

    MDR report key: 23288767 · Received October 15, 2025

    Report

    Report Number
    3007420694-2025-00246
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 14, 2025
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    UDI-DI
    05055982756860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARJO SERVICE TECHNICIAN CONTACTED THE CUSTOMER BY PHONE. THE DOCTOR REPORTED THAT ALL THE CONTROL BUTTONS WERE CHECKED AND NONE WERE ENGAGED. THE ARJO TECHNICIAN ASSUMED THAT THE BED MOVEMENT WAS UNINTENTIONALLY ACTIVATED WHEN THE PATIENT¿S LEGS OR THE CAREGIVER PRESSED A BUTTON ON THE REMOTE CONTROL OR CONTROL PANEL. THIS ALIGNS WITH THE POST-MARKET SURVEILLANCE DATA. THE BED CONTINUED TO BE USED AT THE FACILITY, AND THERE WERE NO FURTHER CUSTOMER COMPLAINTS. BASED ON THIS, IT WAS CONCLUDED THAT NO DEVICE MALFUNCTION OCCURRED THAT COULD HAVE CONTRIBUTED TO THE UNINTENDED BED MOVEMENT. THE LOCKOUT BUTTON LOCATED AT ATTENDANT CONTROL PANEL (ACP) CAN BE USED TO PREVENT ACCIDENTAL ACTIVATION OF THE BUTTONS RESPONSIBLE FOR THE BED PLATFORM MOVEMENT. ACCORDING TO THE PRODUCT INSTRUCTION FOR USE (IFU 831.374-EN) ¿LOCK-OUTS FOR BED FUNCTIONS SHOULD BE USED AT STAFF¿S DISCRETION TO PREVENT UNINTENTIONAL OPERATION OF BED.¿ THE CUSTOMER INFORMED THAT THE BED MOVEMENT WAS STOPPED BY ACTIVATION OF AES BY PLACING FEET UNDER THE BED. THE IFU STATES "AES 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." "IF THE BEAM IS INTERRUPTED (EXAMPLE: BY PATIENT'S 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." TO SUM UP, IT SEEMS MOST LIKELY THAT THE CAUSE OF THE UNINTENDED BED MOVEMENT WAS AN UNINTENTIONAL ACTIVATION OF THE BUTTONS ON THE CONTROL PANEL OR REMOTE CONTROL BY THE PATIENT OR CAREGIVER NO DEVICE MALFUNCTION THAT COULD CAUSE UNINTENDED BED MOVEMENT WAS FOUND; THUS, THE BED MET ITS PERFORMANCE SPECIFICATION. THE BED WAS IN USE BY A PATIENT AND THEREFORE IT WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. THE COMPLAINT WAS ASSESSED AS REPORTABLE DUE TO AN ALLEGATION OF UNINTENDED BED MOVEMENT WHILE THE BED WAS IN USE BY A PATIENT. NO INJURY WAS REPORTED. UDI: (B)(4). THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    ARJO BECAME AWARE OF THE EVENT INVOLVING CITADEL PLUS BED FRAME. THE CUSTOMER REPORTED THAT WHEN THE PATIENT MOVED INDEPENDENTLY TO GET OUT OF BED, THE BED AUTOMATICALLY LOWERED AS SOON AS THE PATIENT¿S LEGS EXTENDED BEYOND THE MATTRESS. TO PREVENT THIS, THE CUSTOMER¿S STAFF HAD TO PLACE THEIR FEET UNDER THE BED TO ACTIVATE THE AES (ANTI-ENTRAPMENT SYSTEM). THE CUSTOMER EXPRESSED CONCERN ABOUT THE RISK OF AN INCIDENT AND REQUESTED A REPLACEMENT FOR THE BED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597147 CITADEL PLUS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. FXX21C4D4AKBBB 05055982756860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other