BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2182617 · Received July 15, 2011

    Report

    Report Number
    2182617
    Date Received
    July 15, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SIERRA SCIENTIFIC INSTRUMENTS
    Product Code
    FFX
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING ESOPHAGEAL MOTILITY, THE SIERRA COMPUTER SYSTEM STOPPED WORKING. WHILE THE CATHETER WAS IN THE PT, THE NURSE CALLED THE COMPANY TECHS. BOTH COMPANIES TRIED TO ASSIST, BUT COULD NOT RESOLVE THIS ISSUE. THE CATHETER HAD TO BE REMOVED, MANOSCAN RECALIBRATED AND THE ENTIRE PROCEDURE REPEATED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MANOSCAN 360 MODEL FFX SIERRA SCIENTIFIC INSTRUMENTS A120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR