InjuryMOS
SENSE HEAD COIL 1.5T 8 CH
Received Jul 9, 2014 · Event occurred Jun 6, 2014
Report 1056069-2014-00002 · MDR key 3970972
Device
Product problems
- Insufficient Device Problem Information
Patient
50 YR
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PHILIPS RECEIVED A REPORT OF A HEATING INCIDENT. A PATIENT WAS SCANNED ON AN ACHIEVA MR SYSTEM WITH THE SENSE HEAD COIL. BLISTERING (2ND DEGREE) WAS NOTED AFTER THE EXAMINATION AT THE UPPER REAR TRICEPS AREA OF THE PATIENT'S LEFT ARM. THE TOTAL SIZE OF THE BLISTERS IS REPORTED TO BE COVERING ONE AND A HALF SQUARE INCH.
Additional Manufacturer Narrative
(B)(4). THE INVESTIGATION IS STILL ON GOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SEND TO THE FDA.