BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINIA

    MDR report key: 3601773 · Received January 17, 2014

    Report

    Report Number
    9613299-2014-00001
    Event Type
    Injury
    Date Received
    January 17, 2014
    Date of Event
    December 3, 2013
    Report Date
    December 19, 2013
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K022960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFO WAS NOT PROVIDED BY THE HOSPITAL. INITIAL REPORTER OCCUPATION WAS NOT PROVIDED. DEVICE MANUFACTURE DATE IS NOT AVAILABLE AT THIS TIME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DEVELOPED A BLISTER ON THE ARCH OF THE RIGHT FOOT, AFTER HE/SHE RECEIVED AN ELECTRICAL SHOCK DURING AN EXAM WITH AN (B)(4) SYSTEM. THE BLISTER NEEDED TO BE DRAINED DUE TO INFECTION, BUT NO ADDITIONAL INFO WAS PROVIDED BY THE HOSPITAL IN ORDER TO CONFIRM IF THE SYSTEM DID CAUSE OR CONTRIBUTE TO THIS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44481 INFINIA SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R