BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATITUDE

    MDR report key: 1590472 · Received January 6, 2010

    Report

    Report Number
    1590472
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Date of Event
    December 17, 2009
    Report Date
    January 6, 2010
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    GBT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROBE WAS CALIBRATED AND CHANNELS TESTED TO MAKE SURE THEY WORKED. WHEN PROBE WAS PLACED IN THE PATIENT CHANNEL FIVE LOST ITS CALIBRATION. A RESTING STUDY WAS DONE TO SEE IF PRESSURE WOULD COME BACK, BUT IT NEVER DID. ALL OF THE CONNECTIONS WERE CHECKED TO MAKE SURE THEY WERE INTACT. THE SLIDER PIECES WERE CHECKED TO MAKE SURE THEY WERE CHARGED. THE PROBE WAS PULLED OUT AND A NEW PROBE WAS CALIBRATED AND INSERTED. THE STUDY WAS COMPLETED WITH A NEW PROBE. COMPANY CALLED & RMA# WAS GIVEN TO SEND CATHETER BACK. CATHETER WAS CALIBRATED AND RESTING PRESSURES GOTTEN. WHEN MOVING ON TO SQUEEZES, CHANNEL TWO LOST ITS CALIBRATION. ALL THE CONNECTIONS WERE CHECKED TO MAKE SURE THAT THEY WERE INTACT. THE SLIDERS PIECES WERE CHECKED TO MAKE SURE THEY WERE STILL CHARGED. THE PROBE WAS PULLED OUT AND A NEW PROBE WAS CALIBRATED AND INSERTED. STUDY WAS COMPLETED WITH NEW PROBE. THE COMPANY WAS CALLED AND RMA# GIVEN TO SEND CATHETER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATITUDE CATHETER, ANAL RECTAL MANOMATORY GBT CLINICAL INNOVATIONS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NO OTHER THERAPIES