BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2000

    MDR report key: 3601685 · Received January 17, 2014

    Report

    Report Number
    9611343-2014-00005
    Event Type
    Death
    Date Received
    January 17, 2014
    Date of Event
    December 18, 2013
    Report Date
    December 18, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K022322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER AND WEIGHT WERE NOT PROVIDED BY THE HOSPITAL. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE HEALTHCARE THAT THE INNOVA 2000 SYSTEM EXPERIENCED A LOSS OF X-RAY IMAGING DURING A FLUOROSCOPY PROCEDURE THAT LASTED APPROX 7 MINS. THE SYSTEM RECOVERED AS EXPECTED AND OPERATED SUCCESSFULLY DURING 30 MINS APPROX BEFORE THE REPORTED PT DEATH. IN ORDER TO EVALUATE IF THE REPORTED SYSTEM MALFUNCTION MAY HAVE CAUSED OR CONTRIBUTED TO THE PT DEATH, THE HOSPITAL MEDICAL STAFF HAS BEEN CONTACTED TO GET FURTHER DETAILS ABOUT THE PT MEDICAL CONDITIONS AND THE DETAILED SEQUENCE OF EVENTS. NO RESPONSE HAVE BEEN REC'D TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44551 INNOVA 2000 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death