BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1123865 · Received August 15, 2008

    Report

    Report Number
    2032545-2008-05003
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR THE CAPSULE DID NOT ATTACH TO THE PT'S ESOPHAGUS. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PT, THE CAPSULE FELL OFF INTO THE PT'S MOUTH. 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 Q220901

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 9012B1001| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 9012B1001| ACCESSORY: MODEL 9012B1001| ACCESSORY: MODEL 9012B1001| ACCESSORY: MODEL 9012B1001