BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARJO CITADEL BED ARJO, ALTERNATING AIR BED,

    MDR report key: 11444617 · Received March 8, 2021

    Report

    Report Number
    MW5099856
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    March 2, 2012
    Report Date
    March 5, 2021
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    I HAVE FILLED A MIDAS REPORT FOR THE CITADEL BED IN CCC 15. THE HOB WAS NOT ABLE TO BE RAISED FOR ABOUT 15 MINUTES. THE REQUIRED INTERVENTIONS NECESSARY TO RAISE THE BED TOOK SEVERAL TIMES TO WORK. THE PATIENT BECAME SB DURING THIS TIME. MY CONCERN IS ICP FROM THE HOB BEING LOWERED TOO LONG. IT MAY NOT BE RELATED BUT WAS NOT HELPFUL FOR THIS PATIENT TO BE FLAT FOR 15 MINUTES. THE COMPANY WAS NOTIFIED AND SENDING A TECH TO REVIEW THE BED. THE AMINO GTT WAS STOPPED WITH MD NOTIFICATION OF THE SITUATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338149 ARJO CITADEL BED ARJO, ALTERNATING AIR BED, BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening