INGENIA
Received Mar 31, 2026 · Event occurred Feb 26, 2026
Report 3042177665-2026-000019 · MDR key 24740635
Device
Generic name
Full-body Mri System, Superconducting Magnet
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INGENIA ELITION XCatalog number
781358
Product problems
- Improper or Incorrect Procedure or Method
- Insufficient Device Problem Information
Patient
59 YR · Female
- Burn(s)
- Itching Sensation
- Partial thickness (Second Degree) Burn
- Insufficient Information
Narrative
Description of Event or Problem
PHILIPS RECEIVED A REPORT THAT THE PATIENT UNDERWENT A RIGHT SHOULDER MRI SCAN. THE PATIENT DID NOT PRESS THE NURSE CALL BUTTON DURING THE PROCEDURE. THE ANATOMIC DETAILS OF THE PATIENT VIEW WERE NOT PROVIDED. THE PATIENT WAS POSITIONED SUPINE WITH THEIR RIGHT ARM EXTERNALLY ROTATED, ROLL UNDER THEIR ARM PADDING AND HAND RAILS PUSHED IN, TO KEEP ARM IN PLACE. IT IS REPORTED THE COIL USED FOR THE EXAM WAS THE DS SHOULDER 16 CH 3.0T. THERE WERE NO SPECIFIC DETAILS PROVIDED ABOUT WHAT THE ACTUAL SHOULDER BURN/INJURY IS. THERE WERE ALSO NO DETAILS PROVIDED ON MEDICAL INTERVENTION GIVEN TO THE PATIENT. DUE TO INSUFFICIENT INFORMATION IN THIS CASE, THE SERIOUS INJURY CANNOT BE RULED OUT. THEREFORE, WE HAVE DECIDE TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.
Additional Manufacturer Narrative
PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.