BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 3100

    MDR report key: 3039973 · Received April 3, 2013

    Report

    Report Number
    9611343-2013-00011
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K031637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH UNK. A GE HEALTHCARE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTS A PT DEATH OCCURRED FOLLOWING A NON-RECOVERABLE BOOT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136373 INNOVA 3100 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIG) MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death