BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1002596 · Received February 8, 2008

    Report

    Report Number
    2032545-2008-00570
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    December 26, 2007
    Report Date
    January 7, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFORMATION IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. THE HANDPIECE BROKE WHEN THE CLINICIAN ATTEMPTED TO DEPLOY THE CAPSULE. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q204862

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK