BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 3201868 · Received June 27, 2013

    Report

    Report Number
    1419652-2013-00152
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER DESCRIPTION: 'RESIDENT WAS IN ALENTI CHAIR. THE ALENTI WAS AT A MEDIUM HEIGHT. THE CAREGIVER ROTATED THE CHAIR IN A CIRCULAR DIRECTION. THE RIGHT CASTOR (FROM CHAIR SIDE) FELL OFF. NO INJURIES TO RESIDENT OR CAREGIVER REPORTED.' REF MFR NUMBER: 9611530-2013-00059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293153 ALENTI NONE FSA ARJO HOSPITAL EQUIPMENT AB CD38003-01

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other