BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 3525964 · Received November 19, 2013

    Report

    Report Number
    1419652-2013-00319
    Event Type
    Injury
    Date Received
    November 19, 2013
    Date of Event
    October 10, 2013
    Report Date
    October 17, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z.O.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REP: STAFF WAS TRANSFERRING RESIDENT FROM WHEELCHAIR TO BED VIA SARA 3000 LIFT AND RESIDENT STARTED PUTTING HER ELBOWS IN THE AIR. THE CAREGIVER INFORMED RESIDENT TO PUT THE ELBOWS DOWN OR SHE WILL FALL OUT OF THE SLING BUT THE RESIDENT WAS NOT LISTENING AND NOT COOPERATIVE, PUT HER ARMS EVEN FURTHER UP IN THE AIR AND TOOK HER FEET OF THE LIFT AN SLID DOWN, HANGING IN THE SLING. THE CAREGIVER THEN LOWERED THE RESIDENT, UNHOOKED THE SLING AND PUT RESIDENT GENTLY TO THE GROUND. MFR REF # 3007420694-2013-00058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599484 SARA 3000 NONE FSA ARJOHUNTLEIGH POLSKA SP. Z.O.O. HEA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization