BEUDAMED
    FDA Adverse Event Death Summary report: N

    CALYPSO

    MDR report key: 2960694 · Received February 11, 2013

    Report

    Report Number
    9611530-2013-00012
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED UNDER THE (B)(4) BY THE MFR ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC. FURTHER INFO WILL BE PROVIDED UPON COMPLETION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR: THE PT WAS SEATED ON THE CHAIR IN AN INCORRECT WAY, WITHOUT THE SAFETY BELT IN FRONT OF THE DEVICE (NO PERPENDICULAR WITH THE BACK AGAINST THE ARM). THE PT FELL DOWN AND DIED. THE DEVICE IS IN PERFECT CONDITION EVEN IF IT IS NOT UNDER A SERVICE CONTRACT AT ARJOHUNTLEIGH. THE INCIDENT WAS DUE TO AN INCORRECT USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58356 CALYPSO HYGIENE AND POOL LIFTER FSA ARJO HOSPITAL EQUIPMENT AB CDB6001-01

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death