BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL BED FRAME

    MDR report key: 18787180 · Received February 27, 2024

    Report

    Report Number
    3007420694-2024-00057
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 7, 2024
    Report Date
    February 29, 2024
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SIDE RAIL PANEL PARTIAL DETACHMENT WAS OBSERVED BY THE ARJO REPRESENTATIVE DURING QUALITY CHECK OF THE BED AFTER RETURNING FROM CUSTOMER TO ARJO SERVICE CENTER. THE SIDE RAIL MECHANISM WAS SERIOUSLY DAMAGED. THE LOWER AND UPPER ARM (SIDE RAIL ASSEMBLY COMPONENTS) DETACHED. NO INJURY OCCURRED. THE REVIEW OF POST-MARKET SURVEILLANCE DATA AND THE INVESTIGATION CARRIED OUT REVEALED THAT THE MAIN FACTOR WHICH COULD LEAD TO THE SIDE RAIL PARTIAL DETACHMENT MIGHT BE RELATED TO AN EXCESSIVE FORCE APPLIED TO THE SIDE RAIL. THIS IS IN LINE WITH THE SIDE RAIL CONDITION DESCRIBED BY THE ARJO SERVICE TECHNICIAN AND THE PHOTO EVIDENCE PROVIDED. THE SIDE RAIL WAS MECHANICALLY DAMAGED (LOWER ARM PIN WAS DISLODGED FROM ITS POSITION, ONE UPPER ARM DISCONNECTED CAUSING THE SIDE RAIL PANEL WAS PARTIALLY DETACHED FROM THE SIDE RAIL MECHANISM). THIS MALFUNCTION WAS DETECTED DURING THE DEVICE EVALUATION. THE INSTRUCTIONS FOR USE FOR CITADEL BED (830-213-EN) INCLUDE THE FOLLOWING INSTRUCTION: - "CHECK OPERATION OF SIDE RAILS" - THIS IS A PREVENTIVE MAINTENANCE ACTIVITY TO BE PERFORMED DAILY BY THE CAREGIVER. BASED ON THE ANALYSIS OF THE COMPLAINTS, THE EXTERNAL EXCESSIVE FORCE MUST FIRST COMPROMISE THE INTEGRITY OF THE SAFETY SIDE PRIOR TO BREAKING IT. ARJO DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION SINCE THE SIDE RAIL WAS PARTIALLY DETACHED. THERE IS NO INDICATION THAT THE DEVICE WAS USED FOR A PATIENT TREATMENT WHEN THE MALFUNCTION OCCURRED. THIS COMPLAINT IS DEEMED REPORTABLE DUE TO THE PARTIAL SIDE RAIL DETACHMENT. NO INJURY WAS REPORTED. DATE OF EVENT IS THE ESTIMATED DATE.

    Description of Event or Problem · 0

    THE SIDE RAIL PANEL PARTIAL DETACHMENT WAS OBSERVED BY THE ARJO REPRESENTATIVE DURING QUALITY CHECK OF THE BED AFTER RETURNING FROM CUSTOMER TO ARJO SERVICE CENTER. THE SIDE RAIL MECHANISM WAS SERIOUSLY DAMAGED. THE LOWER AND UPPER ARM (SIDE RAIL ASSEMBLY COMPONENTS) DETACHED. IT IS UNKNOWN IN WHICH CIRCUMSTANCES THE SIDE RAIL DAMAGE OCCURRED. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102773 CITADEL BED FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. CX811A3F3AMAB0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other