BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTROY

    MDR report key: 1853205 · Received September 27, 2010

    Report

    Report Number
    9611530-2010-00067
    Event Type
    Other
    Date Received
    September 27, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (B)(4), ARJO INC, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2010: "A CHILD WAS BEING TAKEN OUT OF THE POOL. THE CHAIR WAS ATTACHED TO THE WHEELED CHASSIS. AT THAT POINT THE CHAIR & CHILD FELL FROM THE CHASSIS. THE CHILD WAS TAKEN TO HOSPITAL FOR OBSERVATION." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTROY LIFT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB GAB1000-01-GB

    Patients

    Seq Age Sex Outcome Treatment
    1