BEUDAMED
    FDA Adverse Event Summary report: N

    INGENUITY TF PET/MR

    MDR report key: 3687404 · Received March 3, 2014

    Report

    Report Number
    1525965-2014-00038
    Date Received
    March 3, 2014
    Report Date
    February 14, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    OUO
    PMA / PMN Number
    K103483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER WAS USING A PHANTOM TO VALIDATE ONE OF THEIR PROTOCOLS ON THEIR INGENUITY TF PET/MR SYSTEM, WHEN THEY NOTICED THE (DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE) DICOM HEADER ON THE 'MR SPECTROSCOPY STORAGE' OF CHEMICAL SHIFT IMAGING (CSI) HAD AN INCORRECT FORMAT TO IDENTIFY ROWS AND COLUMNS. THE CUSTOMER ALSO NOTICED THAT WHEN THE DATA WAS TRANSFERRED TO NON-PHILIPS DEVICE AND PROCESSED WITH DICOM HEADER INFO ACCORDING TO THE DICOM STANDARD; THE SPECTROSCOPIC IMAGES WOULD BE TRANSPOSED AND IMAGE ORIENTATION WOULD BE MISLABELED RESULTING IN A WRONG ORIENTATION OF THE CSI DATA. A SPECTRUM THAT IS NORMALLY LOCATED AT THE TOP RIGHT HAND CORNER WAS NOW LOCATED AT THE BOTTOM LEFT HAND CORNER. THERE WAS NO REPORT OF HARM TO A PT, BYSTANDER OR TRAINED PROFESSIONAL AS A RESULT OF THE ISSUE. THE VALIDATION TESTING WAS ALL DONE USING A PHANTOM WITH NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127953 INGENUITY TF PET/MR OUO PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 882380 NA

    Patients

    Seq Age Sex Outcome Treatment
    1