BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDCARE LIFT

    MDR report key: 11881527 · Received May 25, 2021

    Report

    Report Number
    3007802293-2021-00005
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 25, 2021
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY MAINTENANCE INSPECTED THE LIFT WITHIN A DAY OF THE INCIDENT AND DID NOT FIND ANY ISSUES WITH THE EQUIPMENT. THE SLING WAS INSPECTED AT THE TIME OF THE INCIDENT; NO FAULT WAS FOUND. ON 19MAY2021, THE DISTRIBUTOR ALSO INSPECTED THE LIFT TO CONFIRM IT WAS IN GOOD WORKING ORDER. THE CNA WHO WAS TRANSFERRING THE RESIDENT AT THE TIME OF THE INCIDENT DID NOT HAVE THE SLING POSITIONED AROUND THE RESIDENT PROPERLY. THE STRAPS WERE NOT CRISSCROSSED THROUGH THE LEGS. THIS ALLOWED THE RESIDENT TO FALL FROM THE SLING. ADDITIONALLY, THE FACILITY'S POLICY IS TO UTILIZE TWO CNAS PER TRANSFER. THERE WAS A VISITING NURSE/CNA AGENCY IN THIS CASE WHO DID NOT FOLLOW THE POLICY; ONLY ONE CNA WAS INVOLVED. THE ROOT CAUSE OF THIS INCIDENT IS USER ERROR; THE EQUIPMENT DID NOT MALFUNCTION. THE DISTRIBUTOR CONDUCTED TWO RETRAINING SESSIONS AT THE FACILITY ON 19MAY2021. THE INSTRUCTIONS FOR USE OF THE SLING DESCRIBE THE NECESSITY OF CRISSCROSSING THE LEG STRAPS AND ARE DEEMED ADEQUATE.

    Description of Event or Problem · 1

    A RESIDENT WAS BEING TRANSFERRED WITH A MEDCARE LIFT AND A TOTAL BODY SLING BY ONE CNA. THE RESIDENT WAS DROPPED AND WAS INITIALLY UNINJURED BUT WAS SENT TO THE HOSPITAL FOR OBSERVATION. THE RESIDENT DEVELOPED A BUMP AFTER RETURNING FROM THE HOSPITAL SO WAS SENT TO THE HOSPITAL AGAIN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772294 MEDCARE LIFT MOBILE LIFT FSA HANDICARE USA INC. 400001

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization