BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH CEILING LIFT

    MDR report key: 10355803 · Received August 3, 2020

    Report

    Report Number
    1041130-2020-00001
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 3, 2020
    Manufacturer
    SAVARIA CONCORD LIFT INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE WERE INFORMED THAT ONE OF THE MONARCH CEILING LIFTS WAS INSTALLED ON A NON-COMPATIBLE TRACK SYSTEM AND THE TRACK SYSTEM FAILED RESULTING IN THE UNIT FALLING ON THE PATIENT/NURSE. INVESTIGATION ALLOWS US TO CONCLUDE THAT THE DEALER (THIRD PARTY INSTALLER) DIDN'T FOLLOW THE INSTALLATION INSTRUCTIONS. THE CEILING LIFT FELL FROM THE TURNTABLE DURING OPERATION, THE TURNTABLE GUARDS WERE NOT BEING ADAPTED FOR THE LIFT TO PREVENT THE FALL. MEDICAL DEVICE WAS INSTALLED DESPITE INCOMPATIBILITY. THE MANUFACTURER WAS NOT AWARE OF THE TRANSACTION BEFORE HAND. THE MANUALS ON THE MONARCH LIFT CLEARLY STATE THAT IT MUST NEVER BE INSTALLED ON A COMPETITORS TRACK SYSTEM WITH ANY TURNTABLE OR SWITCHING OPTION. THE PATIENT AND NURSES WERE HIT BY THE FALLING CEILING LIFT. MANUFACTURER AND IMPORTER WERE INFORMED THAT THE PATIENT AND NURSES HAD MINOR BRUISES ON THE ARMS, CHECKED AT HOSPITAL AND QUICKLY RELEASED. THE DEVICE WAS SOLD / INSTALLED BY A LOCAL DEALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824530 MONARCH CEILING LIFT CEILING LIFT FSA SAVARIA CONCORD LIFT INC. M929101-02

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization