inforMED
InjuryLNH

SIEMENS AVANTO 1.5T MRI

Received Feb 19, 2021 · Event occurred Feb 9, 2021

Report MW5099524 · MDR key 11358074

Device

Generic name

System, Nuclear Magnetic Resonance Imaging

Product problems

  • Defective Component

Patient

49 YR

  • Rash
  • Burning Sensation
  • Blister
  • Rash
  • Burning Sensation
  • Blister

Narrative

Description of Event or Problem

DURING AN MRI EXAMINATION, THE PATIENT ALERTED THE TECHNOLOGIST THAT SHE FELT HEATING ON HER UPPER CHEST REGION. THE RADIOLOGIST LOOKED AT THIS AREA AND FOUND NO VISIBLE REDNESS OR BLISTERING AT THAT TIME. THE FACILITY'S BIOTRONICS TEAM WAS NOTIFIED OF THE EVENT. THE MRI COIL THAT WAS USED WAS PULLED FROM CIRCULATION AND SENT BACK TO THE MANUFACTURER. THE FOLLOWING DAY, THE TECHNOLOGIST SPOKE WITH THE PATIENT VIA A PHONE CALL AND THE PATIENT STATED THAT SHE NO LONGER HAD ANY BURNING BUT THAT SHE HAD A RASH (WHICH SHE DESCRIBED AS A "HEAT" RASH) ON HER UPPER CHEST. FDA SAFETY REPORT ID # (B)(4).