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
Manufacturer
Siemens Ag/siemens Healthcare GmbhProduct 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).