BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 2170952 · Received July 12, 2011

    Report

    Report Number
    2170952
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 12, 2011
    Manufacturer
    GIVEN IMAGING
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    A 48 HOUR BRAVO PH CAPSULE DID NOT DEPLOY INTO THE PT'S ESOPHAGUS. THE BRAVO PH CAPSULE WAS ATTACHED TO THE DEVICE WHEN IT WAS REMOVED FROM THE PT'S MOUTH. ATTEMPTS WERE PERFORMED TO PREPARE A SECOND CAPSULE AND THE PRESSURE FOUND ON THE PUMP WAS 500 INSTEAD OF 510. WE SPOKE WITH TECHNICAL SUPPORT AT GIVEN IMAGING WHO SAID THE PUMP MUST READ 510. A NEW PUMP WAS ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING * 14491Q

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR