BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2121 - IQ

    MDR report key: 2133447 · Received June 15, 2011

    Report

    Report Number
    9611343-2011-00045
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    September 30, 2010
    Report Date
    June 15, 2011
    Manufacturer
    GE MEDICAL SYSTEMS S.C.S.
    Product Code
    MQB
    PMA / PMN Number
    K060259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ALLEGEDLY RECEIVED AN UNCONFIRMED INJURY DUE TO POTENTIAL RADIATION OVEREXPOSURE. THE HOSPITAL STATED THAT THERE WAS NO SYSTEM FAILURE OR DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2121 - IQ VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS S.C.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other