BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 2000

    MDR report key: 2101754 · Received May 10, 2011

    Report

    Report Number
    9611343-2011-00041
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 10, 2011
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    MQB
    PMA / PMN Number
    K022322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION HAS BEEN PROVIDED. THE EXACT INCIDENT DATE IS UNKNOWN; HOWEVER, IT IS BELIEVED THAT THE EVENT OCCURRED ON OR BEFORE (B)(6) 2011. THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. REFERENCE MDR 9611343-2011-00001.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMAGES ON THE LIVE MONITOR WERE FLICKERING INTERMITTENTLY DURING FLUOROSCOPY EXPOSURES. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PATIENT INJURY OR DEATH REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1