BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXISKY 600

    MDR report key: 2920074 · Received January 9, 2013

    Report

    Report Number
    9681684-2013-00002
    Event Type
    Death
    Date Received
    January 9, 2013
    Report Date
    December 20, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR ARJOHUNTLEIGH MAGOG INC. ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC. (B)(4)). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCIDENT OCCURRED IN (B)(6) 2012 THAT LEAD TO THE PATIENT'S DEATH. THE NURSES WERE GETTING HIM OUT OF BED AND INTO A CHAIR USING THE CEILING LIFT AND A SEATED SLING. THE PATIENT DEVELOPED A HEMATOMA ON HIS INNER THIGH, WHICH WAS PERHAPS CAUSED BY THE SLING. A CASCADE OF EVENTS FOLLOWED, WHICH UNFORTUNATELY LED TO HIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11989 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FSA ARJOHUNTLEIGH MAGOG INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death