BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 7160404 · Received January 3, 2018

    Report

    Report Number
    9710107-2018-00028
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    July 28, 2016
    Report Date
    January 3, 2018
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE BRAVO WAS RECEIVED IN THE LAB WITH MISSING DATA IN IT. THE MESSAGE ¿EEFACE ERROR¿ IS OCCURRING ONLY IF TRYING UPLOAD THE DATA FROM THE EMPTY RECORDER. THIS SAY TO THAT COMPLAINANT WAS TRYING TO UPLOAD DATA TWICE OR DELETED BEFORE.THE BRAVO RECORDER WAS TESTED IN THE LAB: THE BRAVO RECORDER WAS CALIBRATED BY CAPSULE SIMULATOR, WAS PERFORMED RECORD STUDY FOR 48 HOURS, WITH THE FOLLOWING UPLOAD DATA BY SW ACCUVIEW PH-Z 5.2 - ALL FUNCTIONS WERE SUCCESSFUL. IT IS REPORTED AND KNOWN THAT CUSTOMER STOPPED THE RECORDER AFTER 1 DAY-NOT CLEAR WHY. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE BRAVO RECORDER WORKS PROPERLY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CUSTOMER CALLED REGARDING AN ERROR WHILE ATTEMPTING TO UPLOAD A BRAVO STUDY. THE RECORDER WAS SET FOR A 96 HOUR STUDY. THE PATIENT REPORTED THAT THE RECORDER TURNED OFF THE DAY AFTER THE RECORDING STARTED. A REPEAT PROCEDURE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5827 BRAVO ELECTRODE, PH, STOMACH FFT GIVEN IMAGING LTD., YOQNEAM FGS-0450

    Patients

    Seq Age Sex Outcome Treatment
    1