BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 16495333 · Received March 7, 2023

    Report

    Report Number
    2438477-2022-00139
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    December 26, 2022
    Report Date
    March 7, 2023
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO., LTD
    Product Code
    FSA
    UDI-DI
    00822383135441
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A PATIENT LIFT BY A PROVIDER, WHO STATED THAT "THE END USER WAS BEING LIFTED OFF TOILET WHEN THE LIFT TILTED TO THE LEFT CAUSING THE PATIENT TO FALL TO THE GROUND. THE END USER'S HUSBAND WAS ABLE TO GET THE END USER MOVED TO BED." IT IS UNKNOWN AT THIS TIME WHETHER THERE WAS ANY INJURY OR MEDICAL TREATMENT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625684 DRIVE LIFT FSA SHENYANG HENYI ENTERPRISE CO., LTD 13023SV 00822383135441

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female