BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS CV

    MDR report key: 2182214 · Received July 7, 2011

    Report

    Report Number
    3003768277-2011-00433
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FLUOROSCOPY DOES NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS CV IZI PHILIPS HEALTHCARE 722030

    Patients

    Seq Age Sex Outcome Treatment
    1