BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRIS V3000

    MDR report key: 2161842 · Received July 8, 2011

    Report

    Report Number
    3003768277-2011-00438
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    June 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K910370
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    CUSTOMER REPORTED THAT THE SYSTEM DISPLAYS AN ERROR "X-RAY GENERATOR NOT AVAILABLE". IT WAS STATED THAT THE PT HAS BEEN CATHETERIZED WITH A PROBE THAT HAS BEEN INSERTED INTO THE HEART AND ACTUALLY THEY DO NOT KNOW WHERE IT IS POSITIONED. AT THE MOMENT, THERE IS NO CLARIFICATION FROM THE CUSTOMER CONFIRMING IF OR HOW THE PT WAS INJURED AS A RESULT OF THE INCIDENT. THEREFORE, THE DECISION TO REPORT AS AN ADVERSE EVENT AND A PRODUCT PROBLEM WAS MADE; HOWEVER, IF ADDITIONAL INFO BECOMES AVAILABLE, THAT INDICATES NO INJURY OCCURRED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA TO CHANGE FROM AN ADVERSE EVENT TO PRODUCT PROBLEM ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS V3000 IZI PHILIPS HEALTHCARE 72243

    Patients

    Seq Age Sex Outcome Treatment
    1