BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 7160049 · Received January 3, 2018

    Report

    Report Number
    9710107-2018-00023
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    July 8, 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 RECORDER WAS RECEIVED WITH THE STUDY¿S DATA. UPLOAD DATA BY ACCUVIEW PH-Z 5.2 WAS FAILED, ERROR MESSAGE APPEARED-¿CANNOT UPLOAD DATA¿. CONNECTED THE RECORDER TO SW "BRAVO UTILITY" AND 227 FILES WERE FOUND, THAT CORRESPONDS TO 48 HOURS OF RECORDING TIME. HOWEVER, THE FILES WERE CHECKED IN THE R<(>&<)>D AND IT WAS FOUND THAT THIS FILES ARE EMPTY (MISSING DATA). THEREFORE CUSTOMER COULD NOT SAVE THE STUDY (CORRUPTED FILES). NOTE THAT COMPLAINANT SAID THAT STUDY IS 18 HOURS HOWEVER ACCORDING TO FILES IT IS CLEAR THAT IT WAS 48 HOURS. NOT CLEAR WHAT THE COMPLAINANT SAW AFTER 18 HOURS. MAIN SUSPICION UNKNOWN BUG OF THE SOFTWARE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CUSTOMER CALLED TO REPORT A BRAVO STUDY THAT ENDED AFTER 18 HOURS. THE CUSTOMER REPORTED THEY WERE UNABLE TO SAVE THE STUDY AND THEN IT WAS DELETED FROM THE RECORDER WHEN ATTEMPTING TO UPLOAD THE STUDY. A REPEAT PROCEDURE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4406 BRAVO ELECTRODE, PH, STOMACH FFT GIVEN IMAGING LTD., YOQNEAM FGS-0450

    Patients

    Seq Age Sex Outcome Treatment
    1