inforMED
OtherMOS

PHILLIPS INTERA SCANNER

Received Apr 16, 2003 · Event occurred Mar 26, 2003

Report MW1028160 · MDR key 454470

Device

Generic name

Synergy Body Coil

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Thermal Decomposition of Device
  • Calibration Error
  • Replace

Patient

*

  • Burn(s)
  • Burning Sensation
  • Other (for use when an appropriate patient code cannot be identified)
  • Therapy/non-surgical treatment, aborted/stopped

Narrative

Description of Event or Problem

APPROXIMATELY 8 MINS INTO AN MRI OF THE PELVIS ON A 1.5T PHILLIPS INTERA SCANNER THE PT COMPLAINED OF A "BURNING SENSATION ON THEIR ANTERIOR LEGS" (DESCRIBED AS "HOT AIR COMING FROM ABOVE"). THE SCAN WAS IMMEDIATELY TERMINATED. THE PT SUSTAINED A FIRST DEGREE BURN OF ONE ANTERIOR THIGH AND A SECOND DEGREE BURN OF THE OTHER ANTERIOR THIGH. THE SYNERGY BODY COIL WAS USED DURING THE SCAN. PHILLIPS SERVICE WAS CALLED. ALL SYSTEM CALIBRATIONS WERE WITHIN SMALL DEVIATIONS FROM THE PREVIOUS PREVENTIATIVE MAINTENANCE CHECK. IN ADDITION, 2 OF THE 4 ELEMENTS OF THE SYNERGY BODY COIL COULD NOT BE TESTED AND WERE DIAGNOSED AS "BURNED OUT". THE COIL WAS REMOVED FROM CLINICAL USE AND A NEW COIL ORDERED AND ARRIVED. THE PHILLIPS QA/SAFETY MANAGER (NETHERLANDS) WAS NOTIFIED AND INDICATED THAT THEY ARE AWARE OF 3-5 OTHER BURN INCIDENTS.