BEUDAMED
    FDA Adverse Event Other Summary report: N

    VANDERLIFT

    MDR report key: 2426601 · Received January 3, 2012

    Report

    Report Number
    1933441-2011-00010
    Event Type
    Other
    Date Received
    January 3, 2012
    Date of Event
    November 28, 2011
    Report Date
    December 20, 2011
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SLING CLAIMED TO BE USED IN THIS TRANSFER WAS RETURNED TO US, THE MANUFACTURE FOR EVAL. UPON EVAL, IT WAS DETERMINED THAT THIS SLING WAS NOT SAFE FOR USE IN FACT THE SLING HAD SEVERAL HOLES IN THE BODY, LOSE THREADS ALONG WITH OTHER SIGNS OF WEAR AND SHOULD HAVE BEEN DISCARDED IMMEDIATELY UPON INSP BEFORE USE (AS STATED IN OUR MANUALS). THE SLING IS NOT "IN GOOD CONDITION" AS STATED IN THE REPORT GIVEN TO VANCARE. VANCARE PLACES WARNINGS ON OUR SLINGS, MANUALS AND INSP CHECK LIST TO DISCARD IMMEDIATELY ANY SLINGS THAT ARE "BLEACHED, TORN, CUT, FRAYED OR BROKEN." WE ARE INCLUDING PICTURES IN THIS REPORT OF THE TROUBLED AREAS OF THE SLING THAT WERE TAKEN DURING OUR INSP/EVAL. ALSO OF NOTE IN-SERVICE IS BEING SCHEDULED AT THIS FACILITY IN ORDER TO AGAIN TRAIN STAFF ON THE PROPER PROCEDURES TO INSP SLINGS THAT ARE BEING USED IN TRANSFERS AT THIS FACILITY.

    Description of Event or Problem · 1

    TWO NURSING ASSISTANTS WERE TRANSFERRING A RESIDENT FROM HER BED TO HER WHEELCHAIR. THE STRAP ON THE SLING BROKE CAUSING RESIDENT TO FALL TO THE FLOOR. RESIDENT WAS SENT TO THE HOSP AND FOUND THAT SHE HAD BROKEN HER HIP. I HAVE ENCLOSED PICTURES OF THE ACTUAL SLING BEING USED AND CLEARLY SEE THAT SLING HAD NUMEROUS HOLES IN IT AT THE TIME OF THIS TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANDERLIFT UNI FIT SLING H CLOTH FSA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R