BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BC UNIVERSAL-QLTD-M

    MDR report key: 10843653 · Received November 16, 2020

    Report

    Report Number
    3007802293-2020-00025
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    July 18, 2020
    Report Date
    November 16, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE SLING INVOLVED IN THE INCIDENT WAS DISCARDED AND NOT RETURNED TO THE MANUFACTURER. PHOTOS OF THE SLING AND DISCUSSION WITH THE USER FACILITY WAS USED TO INVESTIGATE THE ISSUE. THE USER MANUAL DESCRIBES THE LIFE CYCLE OF A HANDICARE SLING TO BE 1 WASH PER WEEK FOR UP TO 4 YEARS WHICH IS EQUIVALENT TO ~208 WASH/DRY CYCLES. THE SLING INVOLVED IN THE INCIDENT IS NEARING THE END OF ITS LIFESPAN AS IT HAS BEEN USED AND WASHED MUCH MORE FREQUENTLY. THE STRAP FAILURE IS DUE TO LONG TERM USE FATIGUE. THE INSTRUCTIONS PROVIDED WITH EACH SLING DIRECT THE USER TO VISUALLY INSPECT THE SLING AND STRAPS PRIOR TO AND DURING A PATIENT TRANSFER. THESE INSTRUCTIONS ARE DEEMED SUFFICIENT AND NO CORRECTIVE ACTION IS NECESSARY. ALL SLINGS AT THE FACILITY WERE INSPECTED AND REPLACED AS NEEDED.

    Description of Event or Problem · 1

    AT THE BEGINNING OF A BED-WHEELCHAIR TRANSFER WITH A CEILING LIFT, THE LEG STRAP OF THE SLING BROKE. THE RESIDENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312849 BC UNIVERSAL-QLTD-M PATIENT SLING FSA HANDICARE USA INC. 537320

    Patients

    Seq Age Sex Outcome Treatment
    1