INGENUITY TF PET/MR

Additional Manufacturer Narrative

(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

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.