BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANOSCAN 360

    MDR report key: 2770033 · Received September 24, 2012

    Report

    Report Number
    2770033
    Event Type
    Malfunction
    Date Received
    September 24, 2012
    Date of Event
    August 20, 2012
    Report Date
    September 24, 2012
    Manufacturer
    GIVEN IMAGING LTD
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CLOSED PROGRAM AFTER IT ASKED USER TO "SAVE AND EXIT" AT CLOSE OF STUDY. FOUND AND CLICKED ON PATIENT FILE NAME AND PROMPTED TO "DELETE SHORTCUT", BECAUSE FILE HAD BEEN "CHANGED OR MOVED". MOTILITY STUDY DONE. IT WAS NOT FOUND IN LIST OF PATIENTS. MISSING. USER FOLLOWED "GUIDED PROTOCOL INSTRUCTIONS" BETWEEN CASES TO SET UP NEW STUDY AND PATIENT INFO. GIVEN TECH SUPPORT CALLED. THEY COMMENTED THAT SOMETIMES THE SOFTWARE WILL NOT SAVE DATA ON THE FIRST OR SECOND STUDY IF 2 OR MORE STUDIES ARE PERFORMED BACK TO BACK WITHOUT EXITING AND RE-ENTERING MANOSCAN PROGRAM. THE INFO ABOUT EXITING THE PROGRAM AFTER EACH CASE WAS NOT IN THE MANOVIEW TRAINING OR INSTRUCTION SHEETS. EMPHASIS IN FOLLOWING THE "GUIDED PROTOCOL" PROMPTS WAS STRESSED. PATIENT WILL HAVE TO RETURN TO HAVE TEST REDONE.MANUFACTURER ADVISES THAT SOMETIMES WHEN YOU DO TWO CASES BACK TO BACK IT WILL DROP DATA FROM ONE PATIENT, OR IT WILL ATTACH THE DATA FROM THE SECOND PATIENT TO THE PREVIOUS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANOSCAN 360 SYSTEM, GASTROINTESTINAL MOTILITY FFX GIVEN IMAGING LTD A120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR NO OTHER THERAPIES