BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMOCK SPACER - MEDIUM

    MDR report key: 10710842 · Received October 21, 2020

    Report

    Report Number
    3007802293-2020-00021
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 24, 2020
    Report Date
    December 21, 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 · 0

    THE SLING INVOLVED IN THE INCIDENT WAS RETURNED FOR INVESTIGATION. THE BROKEN LOOP WAS CONFIRMED AS WELL AS SIMILAR DAMAGE ON ANOTHER LOOP ALSO WITH ORANGE STITCHING. NO DAMAGE TO FABRIC OR OTHER STRAPS WAS NOTED. THE ROOT CAUSE OF THE TOP LEFT SHOULDER STRAP LOOP BREAKING IS DUE TO EXCESS WEAR ON THE SHOULDER STRAPS. THE DAMAGE HAS BEEN CAUSED OVER A LONG-TERM PERIOD OF USE. THE FAILURE IS NOT A RESULT OF A SUDDEN PRODUCT MALFUNCTION, BUT RATHER EXCEEDING THE LIFE OF THE PRODUCT. THE INSTRUCTIONS PROVIDED WITH EACH SLING DIRECT THE USER TO VISUALLY INSPECT THE SLING AND STRAPS PRIOR TO AND DURING A PATIENT TRANSFER. THIS DEGRADATION SHOULD HAVE BEEN NOTICED BY THE CAREGIVERS PRIOR TO LIFTING THE PATIENT. THESE INSTRUCTIONS ARE DEEMED SUFFICIENT AND NO CORRECTIVE ACTION IS NECESSARY. ADDITIONAL COMPLAINTS ON LOOPS WITH ORANGE STITCHING WILL BE MONITORED. ALL SLINGS AT THE FACILITY WERE INSPECTED AND REPLACED AS NEEDED.

    Additional Manufacturer Narrative · 1

    WE ARE WAITING ON THE SLING TO BE RETURNED. WHEN RECEIVED, WE WILL CONDUCT AN INVESTIGATION, AND SUBMIT A FOLLOW-UP REPORT WITH OUR FINDINGS.

    Description of Event or Problem · 1

    STAFF HAD PLACED THE RESIDENT IN THE SLING TO BEGIN A TRANSFER, STARTING ON THE RESIDENT'S BED. AS THE RESIDENT WAS STARTING TO BE REPOSITIONED/LIFTED, THE STRAP SNAPPED AT THE TOP LEFT SHOULDER STRAP. THE PATIENT FELL BACK, TO THE SIDE, AND HIT HIS HEAD ON THE BED LEAVING A CUT ON HIS EAR. TWO EXPERIENCED STAFF WERE ASSISTING WITH THE TRANSFER, A CERTIFIED CARE AIDE (RCA), AND A LICENCED PRACTICAL NURSE (LPN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176156 HAMMOCK SPACER - MEDIUM PATIENT SLING FSA HANDICARE USA INC. 8D4400

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR