BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAXI TRANSPORT CHAIR

    MDR report key: 18911848 · Received March 15, 2024

    Report

    Report Number
    18911848
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    November 9, 2023
    Report Date
    November 20, 2023
    Manufacturer
    THREE BEARS(JIANGSU)HEALTHCARE TECHNOLOGY CO.,LTD
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FAMILY OBTAINED WHEELCHAIR FROM HOSPITAL AND TOOK IT OUT TO THE PARKING LOT TO RETRIEVE VISITOR FROM THEIR VEHICLE. WHILE WHEELING THE PATIENT ACROSS THE HANDICAP PART OF THE SIDEWALK, THE WHEELCHAIR WHEEL BROKE, AND THE VISITOR FELL TO THE GROUND. MANUFACTURER RESPONSE FOR WHEELCHAIR, STAXI TRANSPORT CHAIR (PER SITE REPORTER). FACILITIES MANAGER WAS MAKING THE MANUFACTURER AWARE BY ORDERING A NEW WHEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485484 STAXI TRANSPORT CHAIR CHAIR, ADJUSTABLE, MECHANICAL INN THREE BEARS(JIANGSU)HEALTHCARE TECHNOLOGY CO.,LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female