BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIDIAGNOST

    MDR report key: 2019071 · Received February 4, 2011

    Report

    Report Number
    3003768277-2011-00110
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    January 10, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JAA
    PMA / PMN Number
    K982993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY 04/08/2011.

    Description of Event or Problem · 1

    THE CUSTOMER STATES: "NOT ABLE TO PERFORM A FLUOROSCOPY, LOST DURING STUDY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIDIAGNOST JAA PHILIPS HEALTHCARE 708023

    Patients

    Seq Age Sex Outcome Treatment
    1