BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JASMINE AZ

    MDR report key: 17924126 · Received October 12, 2023

    Report

    Report Number
    9616091-2023-00020
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 13, 2023
    Report Date
    September 15, 2023
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IN OCCURRED IN AUSTRALIA INVOLVING A 9-YEAR-OLD JASMINE LIFT. INVACARE IS FILING THIS REPORT BECAUSE THIS DEVICE IS ALSO SOLD IN THE U.S. THIS DEVICE WAS MANUFACTURED AT INVACARE SUZHOU IN MAY 2014, EXCEEDED ITS SERVICE LIFE OF 5-YEARS AS STATED IN THE USER MANUAL 1150704. INVACARE SUZHOU IS NO LONGER IN BUSINESS, THEREFOR THIS REPORT IS BEING FILED UNDER INVAMEX WHERE THE LIFTS ARE CURRENTLY MANUFACTURED. THIS FAILURE APPEARS TO BE DUE TO THE SCREW/NUT BECOMING STRIPPED LEADING TO THE HANGER BAR BECOMING DETACHED. THE SCALE WAS DISCONTINUED IN NOV 2015, AND AN ALTERNATIVE DESIGN IS NOW USED. IT HAS BEEN REQUESTED THE DEVICE BE RETURNED FOR AN INVESTIGATION. AS OF 10/12/2023, THE LIFT HAS NOT BEEN RECEIVED, THEREFORE, IT IS NOT YET POSSIBLE FOR INVACARE TO DETERMINE THE CAUSE OF THE INCIDENT.

    Description of Event or Problem · 0

    THE CONSUMER WAS USING THE 9-YEAR-OLD JASMINE LIFT, WHEN THE HOLDING SCREW ON THE BOOM FELL CAUSING THE HANGER BAR AND SLING HOOK TO FALL TO THE GROUND. THE PATIENT SUSTAINED A FRACTURED HIP REQUIRING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415301 JASMINE AZ LIFT, PATIENT, NON-AC-POWERED FSA INVAMEX JASMINE AZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention