BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX SCOOP STRETCHER

    MDR report key: 17043772 · Received June 1, 2023

    Report

    Report Number
    3003674698-2023-00345
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    February 2, 2023
    Report Date
    September 13, 2023
    Manufacturer
    JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD
    Product Code
    FPP
    UDI-DI
    00812277037401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DEEMED THAT THE SCOOP STRETCHER WAS BEING USED OFF LABEL, AS THE STRETCHER IS DESIGNED TO BE USED ON A FLAT SURFACE. THERE WAS A LATCH COVER THAT WAS CREATED AND OFFERED TO END USERS CURRENTLY POSSESSING THIS PRODUCT AS AN OPTIONAL ACCESSORY IN THE EVENT THAT IT IS USED OFF LABEL. THE LATCH COVER UNDERWENT PRODUCT TESTING AND APPROVAL BEFORE BEING OFFERED TO END USERS. THE SCOOP STRETCHER LATCH DESIGN WAS CHANGED WITH THE INTENTION TO PREVENT ANY FUTURE INCIDENTS IN WHICH THE LATCH COULD BE ACCIDENTALLY DEPRESSED. THE PRODUCT CHANGE UNDERWENT TESTING PROCEDURES BEFORE THE PRODUCT CHANGE WAS IMPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE LOCKING MECHANISM DID NOT PERFORM AS EXPECTED DURING USE CAUSING THE LATCH TO OPEN WHEN WEIGHT WAS APPLIED AND THE LATCH WAS DEPRESSED. PERFORMANCE OF THE LOCKING MECHANISM WITHIN THE LATCH WAS EVALUATED DURING SIMULATED USE. THE SAME RESULT WAS ABLE TO BE REPLICATED DURING THE SIMULATED USE TESTING.

    Description of Event or Problem · 0

    FOLDING SCOOP STRETCHER LATCHES ARE OPENING WHEN WEIGHT IS APPLIED TO THE STRETCHER AND THE LATCH IS DEPRESSED. THIS WAS BROUGHT TO OUR ATTENTION BY A FEEDBACK RECEIVED STATING THAT THE PATIENT WAS BEING CARRIED DOWN THE STAIRS AND THEY SLID DOWN AND DEPRESSED THE LATCH WITH THEIR FEET CAUSING IT TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898132 CURAPLEX SCOOP STRETCHER FOLDING SCOOP STRETCHER FPP JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD 14781 1504872 00812277037401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown