BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL BED FRAME

    MDR report key: 17580784 · Received August 19, 2023

    Report

    Report Number
    3007420694-2023-00196
    Event Type
    Malfunction
    Date Received
    August 19, 2023
    Date of Event
    July 24, 2023
    Report Date
    September 7, 2023
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPRESENTATIVE PLACED A SERVICE CALL DUE TO A BROKEN LEFT SIDE RAIL ON THE CITADEL BED FRAME. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. NO INJURY WAS REPORTED. THE EVALUATION OF THE DEVICE AND PHOTOGRAPHIC EVIDENCE PROVIDED, REVEALED THAT THE SIDE RAIL WAS PARTIALLY DETACHED FROM THE SIDE RAIL MECHANISM (LOWER ARM PIN HAS DISLODGED FROM ITS POSITION, ONE BEARING PLATE WAS BROKEN IN TWO PIECES). 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 ATTACHED TO THE COMPLAINT RECORD. THE INSTRUCTIONS FOR USE FOR CITADEL BED (830-213-EN) INFORMS 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 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 (LOWER ARM PIN HAS DISLODGED FROM ITS POSITION). NO INJURY WAS REPORTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CITADEL BED SIDE RAIL WAS PARTIALLY DETACHED (LOWER ARM PIN HAD DISLODGED FROM ITS POSITION). NO PATIENT INVOLVEMENT AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073290 CITADEL BED FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. CX811A3F3AMAB0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other