BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXISKY 600

    MDR report key: 3021712 · Received March 21, 2013

    Report

    Report Number
    9681684-2013-00015
    Event Type
    Death
    Date Received
    March 21, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER (B)(4). ON BEHALF OF THE IMPORTER (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    TWO PSW (PERSONAL SUPPORT WORKER) WERE TRANSFERRING THE RESIDENT FROM WHEELCHAIR TO BED, WITH THE ASSISTANCE OF A CEILING LIFT. THE RESIDENT WAS LIFTED UP. WHEN HE WAS BETWEEN WHEELCHAIR AND BED, THE HANGER BAR LET GO FROM THE STRAP AND RESIDENT FELL TO FLOOR. AN UPDATE HAS BEEN RECEIVED ON (B)(6), THE RESIDENT HAS PASSED AWAY. WE DON'T KNOW IF THE DEATH IS COMPLETELY ATTRIBUTABLE TO THE FALL. THERE MAY HAVE BEEN OTHER FACTORS AT PLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118715 MAXISKY 600 MANUFACTURED CEILING FIXED CASSETTES FNG ARJOHUNTLEIGH MAGOG INC. LD10219

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death