BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTILIX 1600 X

    MDR report key: 1277893 · Received November 17, 2008

    Report

    Report Number
    2126677-2008-00094
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KXJ
    PMA / PMN Number
    K790692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PERFORMED BY GE FIELD ENGINEER (FE) REVEALED THAT AN ELECTRIC CO (B) (4) CHANGED THE INPUT PHASES AT THE HOSP THAT REVERSED HOW THE PRESTILIX 1600 X SYSTEM WAS CONNECTED TO THE HOSPITAL'S MAIN POWER. AS A RESULT OF THE REVERSED PHASES, THE TABLE MOVED IN THE UNEXPECTED DIRECTION. ADDITIONAL INSPECTION OF THE SYSTEM REVEALED THAT THE SAFETY LIMIT SWITCH OF THE SYSTEM DID NOT OPERATE PROPERLY, ALLOWING THE TABLE TO CONTACT THE FLOOR. IT IS UNK IF THE REVERSAL OF THE INPUT PHASE AFFECTED THE LIMIT SWITCH. THE FE REPAIRED THE SYSTEM BY REPLACING THE SAFETY LIMIT SWITCH AND CORRECTED THE INPUT POWER PHASE WIRING TO ITS NORMAL CONFIGURATION. THE SYSTEM WAS VERIFIED TO BE PERFORMING ACCORDING TO SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE FOR THE PRESTILIX 1600 X SYSTEM WAS COMMANDED BY THE OPERATOR TO MOVE FROM A VERTICAL POSITION TO A HORIZONTAL POSITION. INSTEAD, THE TABLE MOVED IN THE OPPOSITE DIRECTION AND CONTACTED THE FLOOR. THERE WAS NO INJURY REPORTED. THE CONCERN IS FOR A SERIOUS INJURY IF THE OPERATOR'S FOOT WERE TO BECOME TRAPPED BETWEEN THE TABLE AND FLOOR DURING ITS OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTILIX 1600 X KXJ GE MEDICAL SYSTEMS, LLC 12085A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA