BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1172890 · Received September 19, 2008

    Report

    Report Number
    2032545-2008-05975
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Report Date
    January 29, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE CAPSULE WAS RETURNED SEPARATE FROM THE DELIVERY SYSTEM. THE CAPSULE HAD SOME SALIVA ON IT. NO BLOOD WAS PRESENT. THE CAPSULE FAILED TO ATTACH. THE ANALYST WAS UNABLE TO DETERMINE WHAT CAPSULE BELONGS TO THE DELIVERY SYSTEM.

    Description of Event or Problem · 1

    SEE MANUFACTURING #S: 2032545200802005 AND 203254200802006. THE BRAVO PH MONITOR CAPSULE WAS RETURNED TO THE MANUFACTURER FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q185677

    Patients

    Seq Age Sex Outcome Treatment
    1