BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2627117 · Received June 19, 2012

    Report

    Report Number
    2627117
    Event Type
    Malfunction
    Date Received
    June 19, 2012
    Date of Event
    June 4, 2012
    Report Date
    June 19, 2012
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON HAD ENTERED THE URETHRAL AREA TO BEGIN A TURP CASE. HE WAS USING THE FOOT PEDAL TO PLACE THE PATIENT IN TRENDELENBURG POSITION. HOWEVER, THE BED WENT INTO A DEEP REVERSE TRENDELENBURG. THIS IS THE SECOND FAILURE IN 1.5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TABLE, UROLOGY, C-ARM KXJ BIODEX MEDICAL SYSTEMS, INC. 058-800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR