BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT IMAGING TOP W/GIMBALS (500 LBS)

    MDR report key: 4202633 · Received August 20, 2014

    Report

    Report Number
    2921578-2014-00023
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL'S CHARGE NURSE CALLED THAT LAST NIGHT TOWARD THE END OF AN AAA CASE, THE ANESTHESIOLOGIST WANT TO TILT THE TABLE, USING THE HAND REMOTE, AND ACCORDING THE ANESTHESIOLOGIST, WHEN HE/SHE DID SO, THE TABLE ROTATED QUICKLY PAST WHAT IT NORMALLY DOES. THE PATIENT WAS STRAPPED IN WITH A SAFETY STRAP AND (B)(6) CALLED IT AN "ASSISTED FALL" TO THE GROUND. THE PATIENT WAS BEGINNING TO GAIN CONSCIOUSNESS AT THIS POINT AND WAS EXTUBATED AS A RESULT OF THE "FALL". INJURIES TO THE PATIENT ARE UNKNOWN. THE ANESTHESIOLOGIST CLAIMS THAT BOTH THE ROTATION LOCKS WERE ON AT THIS POINT. (B)(6) IS UNSURE IF THIS WAS USER ERROR OR EQUIPMENT MALFUNCTION AND WANTS THE TABLE INSPECTED TO DETERMINE IF THERE ARE ANY MECHANICAL PROBLEMS WITH THE TABLE. SHE IS TAKING IT OUT OF USE UNTIL IT IS INSPECTED (NOT SURE WHICH OF THE 3 TABLES THIS HOSPITAL OWNS THAT WAS INVOLVED IN THIS INCIDENT). POSSIBLE SERIAL NUMBER SERIAL NUMBERS, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504022 RADIOLUCENT IMAGING TOP W/GIMBALS (500 LBS) TABLE SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other