BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1003445 · Received February 21, 2008

    Report

    Report Number
    2032545-2008-00848
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 22, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. IF FURTHER INFO IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE HCP REPORTED, THAT WHILE PLACING A BRAVO PH MONITOR, THE CAPSULE WOULD NOT ATTACH TO THE PT'S ESOPHAGUS. THE CAPSULE FELL OFF IN THE PT'S MOUTH. THE PHYSICIAN FELT THAT THE CAPSULE NOT ATTACHING MAY HAVE BEEN DUE TO A LARGE AMOUNT OF PHLEGM PRESENT. NO SERIOUS INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q193169

    Patients

    Seq Age Sex Outcome Treatment
    1