BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL BED FRAME

    MDR report key: 18226405 · Received November 29, 2023

    Report

    Report Number
    3007420694-2023-00286
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 7, 2023
    Report Date
    November 29, 2023
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    UDI-DI
    05055982755764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF PICK UP A CITADEL BED FRAME BY AN ARJO REPRESENTATIVE, IT WAS OBSERVED THAT THE RIGHT FOOT END SIDE RAIL WAS DAMAGED. PHOTOGRAPHIC EVIDENCE PROVIDED CONFIRMED THAT THE SIDE RAIL PANEL WAS COMPLETELY DETACHED FROM BRACKETS. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS REPORTED. 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 SIDE RAIL CONDITION DESCRIBED BY THE ARJO REPRESENTATIVE AND THE PHOTO EVIDENCE PROVIDED (SAFETY SIDE RAIL PANEL COMPLETELY DETACHED FROM BRACKETS). THE INSTRUCTIONS FOR USE FOR CITADEL BED (830-213-EN) STATES TO "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. TO CONCLUDE, ARJO DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION SINCE THE SIDE RAIL WAS 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 RIGHT FOOT END SIDE RAIL DETACHMENT. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    AT THE TIME OF PICK UP A CITADEL BED FRAME BY AN ARJO REPRESENTATIVE, IT WAS OBSERVED THAT THE RIGHT FOOT END SIDE RAIL WAS DAMAGED. PHOTOGRAPHIC EVIDENCE PROVIDED CONFIRMED THAT THE SIDE RAIL PANEL WAS COMPLETELY DETACHED FROM THE BRACKETS. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS REPORTED. THE CIRCUMSTANCES IN WHICH THE ISSUE OCCURRED ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66782 CITADEL BED FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. 05055982755764

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other