BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE RELIANT PLUS 450, MODEL R113 SLING

    MDR report key: 274873 · Received April 21, 2000

    Report

    Report Number
    MW1018729
    Event Type
    Injury
    Date Received
    April 21, 2000
    Date of Event
    April 8, 2000
    Report Date
    April 14, 2000
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSING HOME RESIDENT WAS BEING TRANSFERRED BY AN ELECTRIC LIFTING DEVICE WITH TWO NURSE AIDES IN ATTENDANCE. EVENT OCCURRED IN RESIDENT'S ROOM. A NYLON SLING WAS POSITIONED UNDER THE RESIDENT, ACCORDING TO PROCEDURE, AND LOOPS ON THE SUPPORT STRAPS WERE ATTACHED TO THE LIFT PER PROCEDURE. AS THE LIFT WAS OPERATED TO RAISE THE PERSON AND TOOK ON PT'S FULL WEIGHT, ONE OF THE LOOPS ON A SUPPORT STRAP (4 STRAPS USED) DETACHED WHEN STITCHING SECURING THE LOOP TO THE STRAP SEPARATED, THEREBY CAUSING THE SUPPORT STRAP TO BE RELEASED. THE SUDDEN IMBALANCE IN THE LIFT TOSSED THE RESIDENT ONTO THE FLOOR FROM A HEIGHT OF APPROX 3 FEET. UPON EXAMINATION OF THE SLING IT WAS FOUND THAT ANOTHER SUPPORT LOOP'S STITCHING CAME APART WHEN TESTED BY HAND. THIS SLING WAS BRAND NEW AND HAD ONLY BEEN PUT INTO USE ON THE PREVIOUS DAY. SLING SHOWED NO SIGNS OF WEAR OR DEFECT, BUT AFTER EVENT IT WAS DETERMINED THAT THE STITCHING FOR THE TWO LOOPS HAD NOT GONE ALL THE WAY THROUGH THE NYLON FABRIC ON BOTH SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE RELIANT PLUS 450, MODEL R113 SLING SLING FOR ELECTRIC LIFT FNG INVACARE CORPORATION R113 SLING L 9 2755

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R NONE AT THIS TIME.