BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL BED FRAME

    MDR report key: 16822094 · Received April 27, 2023

    Report

    Report Number
    3007420694-2023-00086
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    April 8, 2023
    Report Date
    April 27, 2023
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    UDI-DI
    05055982755764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF POST-MARKET SURVEILLANCE DATA REVEALED THAT THE MAIN FACTOR WHICH COULD LEAD TO THE SIDE RAIL DETACHMENT MIGHT BE RELATED TO AN EXCESSIVE FORCE APPLIED TO THE SIDE RAIL. THIS IS IN LINE WITH THE BED FRAME CONDITION (THE PIN THAT IS PART OF THE SIDE RAIL MECHANISM WAS MISSING CAUSING DETACHMENT OF THE SIDE RAIL LOWER ARM AND BOTH SIDE RAIL UPPER ARMS). THE INSTRUCTIONS FOR USE FOR CITADEL BED (830-213-EN) INCLUDE THE INSTRUCTIONS FOR SAFE OPERATION TO AVOID DAMAGE OF THE SIDE RAILS AS FOLLOWS: - "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 DETACHMENT. ARJO DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION SINCE THE SIDE RAIL PIVOT PIN WAS MISSING. THERE IS NO INDICATION OF PATIENT INVOLVEMENT WHEN THE MALFUNCTION OCCURRED. THIS COMPLAINT IS DEEMED REPORTABLE DUE TO THE SIDE RAIL DETACHMENT FROM THE BED FRAME (THE PIN THAT IS PART OF THE SIDE RAIL MECHANISM WAS MISSING CAUSING DETACHMENT OF THE SIDE RAIL LOWER ARM AND BOTH SIDE RAIL UPPER ARMS). NO INJURY WAS CLAIMED.

    Description of Event or Problem · 0

    ARJO RECEIVED A CUSTOMER COMPLAINT REGARDING A CITADEL BED FRAME. THE CUSTOMER INFORMED ABOUT THE SIDE RAIL MALFUNCTION. IT WAS ALLEGEDLY BROKEN. THE DEVICE EVALUATION CONFIRMED THE ALLEGATION, THE SIDE RAIL WAS DETACHED FROM THE BED FRAME. NO PATIENT WAS INVOLVED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625977 CITADEL BED FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. CX811A3F3AMAB0 05055982755764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other