BEUDAMED
    FDA Adverse Event Death Summary report: N

    PAL

    MDR report key: 108091 · Received July 23, 1997

    Report

    Report Number
    2132280-1997-00001
    Event Type
    Death
    Date Received
    July 23, 1997
    Date of Event
    June 5, 1997
    Report Date
    July 14, 1997
    Manufacturer
    SUNRISE MACHINE AND TOOL, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSING ASSISTANTS WERE USING PAL LIFT WITH PHYSICALLY AND NEUROLOGICALLY IMPAIRED RESIDENT. A SLING WITHOUT LEG STRAPS WAS USED. THE RESIDENT HAD SOME SORT OF SEIZURE WHILE BEING LIFTED AND SLID OUT OF THE SLING STRIKING HEAD ON FLOOR. THE RESIDENT EXPIRED THE FOLLOWING DAY. HAD THE NURSES AIDES USED THE TYPE OF SLING WITH THE LEG STRAP THE RESIDENT WOULD NOT HAVE FALLEN. HOYER LIFT SLING UTILIZED WITH PAL LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAL PATIENT LIFTER FSA SUNRISE MACHINE AND TOOL, INC. PC250R *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death