BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMOTION PATIENT CHAIR

    MDR report key: 12048609 · Received June 23, 2021

    Report

    Report Number
    12048609
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 3, 2021
    Report Date
    June 18, 2021
    Manufacturer
    WINCO MFG., LLC
    Product Code
    GBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE WERE FINISHED WITH THE ABLATION PROCEDURE AND READY TO TRANSFER THE PATIENT FROM THE OPERATING TABLE OVER TO THE CART. AFTER PLACING A SLIDER BOARD AND SLIDER SHEET UNDERNEATH THE PATIENT, WE PULLED THE PATIENT OVER TO THE CART. ONCE THE PATIENT WAS ON THE CART (BLACK CARTS THAT ARE CONVERTIBLE TO CHAIRS) THE CART STARTED TIPPING DOWNWARD. THE PATIENT'S HEAD OF THE CART STARTED TO SLANT DOWNWARD AND THE PATIENT STARTED TO SLIDE DOWN HEAD FIRST. SOMEONE YELLED "THE PATIENT IS GOING DOWN!" WE QUICKLY GRABBED THE CART AND LIFTED UPWARD. WE WERE ABLE TO LEVEL OUT THE CART AND TRANSFER THE PATIENT BACK TO RECOVERY WITHOUT HARM. THE SLANTING OF THE CART IS A PATIENT SAFETY ISSUE. IT WAS UNCLEAR IF THE HYDRAULICS WERE TO BLAME OR IF THE CART WAS TOP HEAVY. IN ANY CASE, THE CART SHOULD NOT BE TIPPING OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948615 TRANSMOTION PATIENT CHAIR CHAIR, SURGICAL, AC-POWERED GBB WINCO MFG., LLC

    Patients

    Seq Age Sex Outcome Treatment
    1