BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL BED FRAME

    MDR report key: 18272779 · Received December 6, 2023

    Report

    Report Number
    3007420694-2023-00293
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 6, 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

    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 SIDE RAIL CONDITION AND THE PHOTOGRAPHIC EVIDENCE PROVIDED. THE SIDE RAIL LOWER ARM (PART OF THE SIDE RAIL ASSEMBLY) WAS DISCONNECTED FROM THE BED CAUSING THE SIDE RAIL WAS PARTIALLY DETACHED AND DID NOT LOCK. THE DEVICE EVALUATION REVEALED ALSO THE MISSING HEADBOARD HOWEVER IT IS NOT RELATED TO THE SIDE RAIL DETACHMENT. 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 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 SIDE RAIL PARTIAL DETACHMENT. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    THE INSPECTION OF THE CITADEL BED CONDUCTED BY AN ARJO SERVICE TECHNICIAN REVEALED THE PARTIALLY DETACHED SIDE RAIL PANEL. THE SIDE RAIL LOWER ARM (PART OF THE SIDE RAIL ASSEMBLY) WAS DISCONNECTED FROM THE BED. NO PATIENT WAS INVOLVED AT THAT TIME. NO INJURY WAS CLAIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160437 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