BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIO VASCULAR SYSTEM

    MDR report key: 2020566 · Received February 10, 2011

    Report

    Report Number
    3003768277-2011-00137
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA BY 04/10/2011.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUORO DOSE IS TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIO VASCULAR SYSTEM NA IZI PHILIPS HEALTHCARE 72200

    Patients

    Seq Age Sex Outcome Treatment
    1