inforMED
InjuryLNH

3 TESLA GE SIGNA ARCHITECT MRI SYSTEM

Received Jul 14, 2026 · Event occurred Jun 30, 2026

Report MW5190725 · MDR key 25816765

Device

Generic name

System, Nuclear Magnetic Resonance Imaging

Patient

60 YR · Female

  • Flashers
  • Burning Sensation
  • Vitreous Detachment

Narrative

Description of Event or Problem

REPORTER SAYS THAT ON (B)(6), SHE UNDERWENT A BREAST MRI AT (B)(6) USING A 3 TESLA GE SIGNA ARCHITECT SCANNER. DURING THE PROCEDURE, SHE EXPERIENCED SEVERE OVERHEATING AND A BURNING SENSATION ACROSS HER BACK AND TORSO, WHICH SUBSEQUENTLY TRIGGERED A POSTERIOR VITREOUS DETACHMENT IN HER LEFT EYE. FOLLOWING THE SCAN, SHE BEGAN SEEING FLASHING LIGHTS AND A BLACK CURTAIN IN HER VISION, PROMPTING HER TO SEEK IMMEDIATE MEDICAL ATTENTION AT THE EMERGENCY ROOM, AN OPHTHALMOLOGIST, AND A RETINA SPECIALIST. ADDITIONALLY, THE TECHNICIAN LEFT MIDWAY THROUGH THE EXAM, AND ALTHOUGH THE PATIENT WAS SUPPOSED TO BE ABLE TO INTERCOM WITH THEM, THE COMMUNICATION WAS MUFFLED AND THEY COULD NOT CONNECT. THIS INCIDENT WAS COMPLAINED ABOUT AND REPORTED DIRECTLY TO THE (B)(6) MANAGER, (B)(6), WHO ACKNOWLEDGED THE REPORT BUT STATED THAT THE FACILITY WAS NOT OBLIGATED TO REPORT THIS EQUIPMENT MALFUNCTION.