BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL BED FRAME

    MDR report key: 18370730 · Received December 21, 2023

    Report

    Report Number
    3007420694-2023-00306
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    December 6, 2023
    Report Date
    December 21, 2023
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    UDI-DI
    05056097342184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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/ DAMAGE MIGHT BE RELATED TO AN EXCESSIVE FORCE APPLIED TO THE SIDE RAIL. THIS IS IN LINE WITH THE SIDE RAIL CONDITION. THE BOTH UPPER ARMS THAT ARE PART OF THE SIDE RAIL ASSEMBLY WERE DISCONNECTED FROM THE BED. THE INSTRUCTIONS FOR USE FOR CITADEL BED (830-213-EN) STATE TO: ¿MAKE SURE THE LOCKING MECHANISM IS SECURELY ENGAGED WHEN THE SIDE RAILS ARE RAISED.¿ ADDITIONALLY, THE CAREGIVER SHOULD CHECK OPERATION OF THE SIDE RAILS DAILY. IF THE RESULT OF THE TEST IS UNSATISFACTORY, CONTACT ARJO. BASED ON THE ANALYSIS OF THE COMPLAINTS, THE EXTERNAL EXCESSIVE FORCE MUST FIRST COMPROMISE THE INTEGRITY OF THE SAFETY SIDE PRIOR TO DETACHMENT. THE 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 SIDE RAIL DETACHMENT. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    THE SIDE RAIL WAS DETACHED FROM THE CITADEL BED FRAME. THE BOTH UPPER ARMS THAT ARE PART OF THE SIDE RAIL ASSEMBLY WERE DISCONNECTED FROM THE BED. THERE WAS NO INDICATION THAT THE BED FRAME WAS IN USE WHEN THE ISSUE OCCURRED. NO INJURY WAS CLAIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034847 CITADEL BED FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. CX611B3F4AMAB0 05056097342184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other