BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    500LB SMART STAND WITH SCALE

    MDR report key: 17751058 · Received September 14, 2023

    Report

    Report Number
    2183887-2023-00004
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 14, 2023
    Report Date
    September 14, 2023
    Manufacturer
    EZ WAY, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FACILITY ATTEMPTED TO REPAIR THE UNIT BY WELDING IT. THIS ACTION PREVENTS A PROPER ANALYSIS OF THE ORIGINAL WELD CONDITION. SECTION D8 - THIRD PARTY SERVICE CONDUCTED BY GE HEALTHCARE AS LISTED IN SECTION B5. SECTION H6 - NO REPORT OF INJURY TO THE RESIDENT WAS REPORTED BY THE FACILITY FOR THIS INCIDENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE, "NURSING STAFF WERE TRANSFERRING PATIENT FROM HER BED TO CHAIR WITH THE LIFT. PATIENT WAS ATTACHED TO THE LIFT VIA THE STRAPS AND SLING. LIFT ARM BROKE AND PATIENT FELL ON THE FLOOR LANDING ON HER BUTTOCKS. STRAPS REMAINED ATTACHED SO THE PATIENT REMAINED SITTING UPRIGHT ON THE FLOOR." CUSTOMER REPORTED THEIR MAINTENANCE STAFF FOLLOWS A MONTHLY INSPECTION SCHEDULE FOR THE UNIT INVOLVED IN THE INCIDENT. A MAINTENANCE RECORD PROVIDED BY THE CUSTOMER DOES NOT LIST THE SERIAL NUMBER OF THE UNIT IDENTIFIED IN THE INCIDENT. THE MAINTENANCE RECORDS PROVIDED BY THE CUSTOMER SHOW THE LAST INSPECTION WAS COMPLETED ON 03-AUG-2023. PRIOR INSPECTION RECORDS WERE PROVIDED BY THE CUSTOMER DATED (B)(6) 2023 AND (B)(6) 2023 SHOWING INSPECTIONS WERE COMPLETED, THESE RECORDS DO NOT LIST THE IDENTIFIED UNIT INVOLVED IN THE INCIDENT. INSTRUCTIONS INCLUDED IN THE INSPECTION LIST, #3 RAISE AND LOWER A TEST LOAD WHILE LOAD IS ATTACHED TO STAND. CHECK ALL STRUCTURAL WELDS FOR SIGNS OF STRESS OR CRACKING. IF FOUND, REMOVE LIFT FROM SERVICE UNTIL REPAIRS HAVE BEEN COMPLETED." WEIGHT OF THE LOAD TO TEST THE UNIT IS NOT LISTED. CUSTOMER REPORTED UNIT INSPECTIONS ARE ALSO PERFORMED BY GE HEALTHCARE. THE MAINTENANCE RECORDED FROM THE GE HEALTHCARE INSPECTION SHOW THE LAST INSPECTION FOR THIS UNIT WAS COMPLETED ON 03-AUG-2023. CHECKLIST DETAILS LISTS: CHECK MECHANICAL INTEGRITY & CONDITION: NO UNSAFE, DAMAGED, DEFECTIVE, MISSING PARTS, & MORE. SECTION IS RATED AS PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268361 500LB SMART STAND WITH SCALE STAND AID FSA EZ WAY, INC. S500PS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male