SENSE XL TORSO COIL, 1.5T MK2
Received Apr 2, 2025 · Event occurred Dec 24, 2022
Report 1051786-2025-000005 · MDR key 21750751
Device
Generic name
Sense Xl Torso Coil, 1.5t Mk2
Manufacturer
Philips Electronics Nederland B.v.Model number
453567502284Catalog number
SENSE XL TORSO COIL, 1.5T MK2
Product problems
- No Apparent Adverse Event
- Insufficient Device Problem Information
- No Apparent Adverse Event
- Insufficient Device Problem Information
Patient
42 YR · Male
- Full thickness (Third Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
PHILIPS RECEIVED REPORT FROM A PATIENT WHO CLAIMED TO HAVE RECEIVED A BURN DURING AN MR EXAMINATION. THIS INJURY EXACERBATED OVER TIME EVENTUALLY LEADING TO AMPUTATION OF THE TOP OF THE 2ND FINGER ON THE RIGHT HAND. THE PATIENT INDICATES THAT THIS IS LINE TO THE KNOWN ISSUE OF THE XL TORSO COIL KNOWN TO THE FDA UNDER (B)(4).
Additional Manufacturer Narrative
PHILIPS HAS STARTED AN INVESTIGATION INTO THIS ALLEGED EVENT. INITIAL FINDINGS: THERE IS NO RECORD OF A PHILIPS MRI MACHINE INSTALLED AT THE SITE MENTIONED BY THE PATIENT. THERE IS ALSO NO RECORD OF A XL TORSO COIL LINKED TO THE SITE MENTIONED BY THE PATIENT.
Additional Manufacturer Narrative
PHILIPS HAS PERFORMED AN INVESTIGATION INTO THIS ALLEGED INCIDENT. IT WAS CONCLUDED THAT NO PHILIPS MR SYSTEM NOR AN XL TORSO WAS INSTALLED AT THIS SITE AT ANY MOMENT. THE CUSTOMER CONFIRMED VERBALLY THAT THEY ARE USING NO PHILIPS MR SYSTEMS BUT MR SYSTEMS PROVIDED BY GE HEALTHCARE.