BEUDAMED
    FDA Adverse Event Summary report: N

    INGENUITY CORE 128

    MDR report key: 3020568 · Received March 20, 2013

    Report

    Report Number
    1525965-2013-00061
    Date Received
    March 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. AT THIS TIME. WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION THAT THE CUSTOMER REPORTED WHEN PERFORMING A CT PERFUSION STUDY, THE PT'S IMAGES WERE INTERPRETED AS THE PT HAVING A STROKE AND THAT THE DAMAGE TO THE BRAIN COULD NOT BE REPAIRED. THE PHYSICIAN PERFORMED AN INTERVENTION ON THE PT AND THE PT RECOVERED. THE CUSTOMER ALLEGED THE CT BRAIN PERFUSION RESULTS WERE NOT CORRECT. NO ADDITIONAL INFORMATION REGARDING THE PT'S CONDITION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116715 INGENUITY CORE 128 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728323

    Patients

    Seq Age Sex Outcome Treatment
    1