BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE WITH DELIVERY SYSTEM

    MDR report key: 2032739 · Received February 21, 2011

    Report

    Report Number
    2032739
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GIVEN
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BRAVO PH MONITORING CAPSULE FAILED TO DEPLOY IN ESOPHAGUS. EXCELLENT SUCTION OF 800 MM APPLIED, DEPRESSED PLUNGER AS PER PROTOCOL, 1/4 TURN, PLUNGER POPPED UP AND INTRODUCER REMOVED. CAPSULE HAD CALIBRATED APPROPRIATELY. ON CHECKING WITH THE ENDOSCOPE, NO PH PROBE WAS ATTACHED TO THE ESOPHAGUS, IT WAS STILL IN PLACE ON THE INTRODUCER. A NEW CAPSULE WAS CALIBRATED AND DEPLOYED WITH SUCCESS IN ESOPHAGUS. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO PH CAPSULE WITH DELIVERY SYSTEM BRAVO PH CAPSULE WITH DELIVERY SYSTEM FFT GIVEN * 2010-08/13836Q

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR