BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDRAULIC LIFT BASE

    MDR report key: 19873 · Received February 17, 1995

    Report

    Report Number
    MW1005175
    Event Type
    Other
    Date Received
    February 17, 1995
    Date of Event
    January 25, 1995
    Report Date
    January 30, 1995
    Manufacturer
    MXE, INC.
    Product Code
    FSA
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AT ABOUT 10:30 AM ON 1/25/95 THE CHAIR WAS BEING USED DURING A PROCEDURE IN A MAMMOGRAPHY X-RAY ROOM. A MAMMOGRAPHY TECHNOLOGIST SAID THAT DURING THIS PROCEDURE AFTER NEEDLE WAS PLACED IN THE PT'S BREAST, THE PT COMMENTED THAT THE CHAIR FELT KIND OF FUNNY OR WOBBLY. THE TECHNOLOGIST THEN BEGAN TO ASSIST THE PT IN STANDING UP. AT THIS TIME THE PEDESTAL BECAME SEPARATED FROM THE BASE AND FELL TO THE FLOOR. CLINICAL ENGINEERING EXAMINED THE CHAIR. THE BOLTS SECURING THE BASE TO THE HYDRAULIC PEDESTAL HAD PULLED OUT OF THE METAL STRIPPING THE INTERNAL THREADS OF THE PEDESTAL. THE BOLTS WERE SCREWED IN APPROX 1/4" TO THE PEDESTAL BASE AS EVIDENCED BY THE LENGTH OF THE BOLTS AND THE SPIRAL THREAD REMAINING WRAPPED AROUND THE BOLT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAULIC LIFT BASE CHAIR FSA MXE, INC. MXE1A-MXE04CF-21H

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other