BEUDAMED
    FDA Adverse Event Summary report: N

    INGENUITY TF PET/MR

    MDR report key: 2483586 · Received February 28, 2012

    Report

    Report Number
    1525965-2012-00004
    Date Received
    February 28, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    OUO
    PMA / PMN Number
    K103483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS A REMOTE POTENTIAL FOR FALSE-NEGATIVE INTERPRETATION IN PTS WITH NEOPLASM THAT COULD RESULT IN LACK OF TREATMENT LEADING TO THE NECESSITY FOR MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT. THERE WAS NO REPORT OF HARM TO A PT IN THIS CASE AND THE HARM IS NOT EXPECTED TO OCCUR DUE TO TRAINED INTERPRETING PHYSICIAN RECOGNIZING IMAGE ARTIFACT, AND DEFAULT DISPLAY OF NON-AC AND ATTENUATION MAP FOR COMPARISON. INSTRUCTIONS FOR USE INCLUDES REVIEW OF NON-ATTENUATION CORRECTION IMAGES (459800153451 REV. B P18). THIS REPORTED EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A CUSTOMER COMPLAINT STATING A PHOTOPENIC ARTIFACT WAS DETECTED THROUGH THE LOWER LUNGS ON THE MAGNETIC RESONANCE ATTENUATION CORRECTED (MRAC) IMAGE. THE CUSTOMER ALSO NOTICED LOW UPTAKE IN THE INFERIOR WALL OF THE HEART THAT WAS ALSO DETECTED ON THE NON-ATTENUATION CORRECTIVE (NAC) IMAGES. THE ARTIFACT IS NOT PRESENT ON THE MR MAP OR NAC DATASET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INGENUITY TF PET/MR INGENUITY TF PET/MR OUO PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 882380

    Patients

    Seq Age Sex Outcome Treatment
    1