BEUDAMED
    FDA Adverse Event Injury Summary report: N

    600 LB SMART LIFT WITH SCALE

    MDR report key: 19485139 · Received June 7, 2024

    Report

    Report Number
    2183887-2024-00001
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    October 20, 2023
    Report Date
    June 6, 2024
    Manufacturer
    EZ WAY INC
    Product Code
    FSA
    UDI-DI
    00848914000019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS MADE TO INVESTIGATE THIS INCIDENT AND GATHER ADDITIONAL INFORMATION. THEY WENT TO THE HOSPITAL AND CAME BACK TO THE NURSING HOME. ARRIVED AT FACILITY, MET BRANDON(MAINTENANCE DIRECTOR IN THE FOYER AREA. WE WENT TO CONFERENCE ROOM TO MEET WITH ASSISTANT DIRECTOR OF NURSING AND UNIT NURSE. WE DISCUSSED THE INCIDENT THE WAS ON (B)(6) 2023. BRANDON ADVISED THAT HE CHECKED THE UNIT RIGHT AFTER THE INCIDENT. HE SAID THE UNIT WAS IN PROPER WORKING CONDITION. ALL 3 SAID IT WAS NOT THE UNIT(LIFT), IT WAS OPERATOR ERROR. THERE WERE 2 CAREGIVERS WHEN THE INCIDENT OCCURRED. THEY ARE NO LONGER AT THIS FACILITY. THE INCIDENT HAPPENED DOING A TRANSFER FROM THE BED TO CHAIR. ASKED ABOUT THE RESIDENTS HEALTH, THEY MENTIONED SHE HAS MULTIPLE PREEXISTING CONDITIONS. THERE WERE NO MEDICAL CODES NOTED. WE ALSO DISCUSSED FUTURE INSERVICES. LEFT CARD AND CATALOG. WE WILL FOLLOW UP IN 2 WEEKS.

    Description of Event or Problem · 0

    2 CAREGIVERS TRANSFERRING RESIDENT FROM BED TO CHAIR AND RESIDENT FELL. CARISSA SAID ONE OF THE HARNESS STRAPS CAME OFF THE STAND. THE RESIDENT FELL AND HAD A FRACTURED FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423896 600 LB SMART LIFT WITH SCALE LIFT FSA EZ WAY INC L600PS-03 00848914000019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention