inforMED
InjuryMOS

SENTINELLE ARRAY BREAST COIL

Received Jan 16, 2016 · Event occurred Jan 4, 2016

Report MW5059480 · MDR key 5383821

Device

Generic name

Sentinelle Array Breast Coil

Product problems

  • Failure of Device to Self-Test

Patient

74 YR

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

SIEMENS MAGNETOM ESPREE 1.5T MRI SCANNER WITH THE SENTINELLE VANGUARD BREAST COIL; (FOR SIEMENS BREAST MRI AUXILIARY TABLE WITH 2/4/8- CHANNEL COIL ARRAY BREAST COIL) WAS UTILIZED ON PATIENT FOR MRI OF THE BREAST. THE PATIENT REPORTED RIGHT SIDED BURNING OF THE RIGHT FLANK REGION IMMEDIATELY AFTER THE MRI EXAM. UPON ASSESSMENT BY THE TECHNOLOGIST, REDNESS WAS OBSERVED IN THE REPORTED AREA BY THE PATIENT. THE NEXT DAY, THE PATIENT WAS EVALUATED AND TREATED BY HER PHYSICIAN FOR BLISTERING ON RIGHT SIDE OF HER ABDOMEN AND HER RIGHT FOREARM. CONTRIBUTING FACTORS; RF POWER WAS BEING TRANSMITTED BY THE BODY COIL; AND THE TRANSMITTED RF POWER WAS BEING TRANSMITTED TO A VOLUME/ANATOMY THAT DID INCLUDE THE ABDOMEN AND FOREARM. SUSPECT PATIENT'S FOREARM AND ABDOMEN WERE TOUCHING, (AND RIGHT AT THE LEVEL OF THE THERMAL INJURY), DURING THE EXAMINATION. THE ELECTRICAL CONDUCTIVITY OF POSSIBLE PERSPIRATION MIGHT WELL HAVE BEEN RELATED TO THE OBSERVED OUTCOME. THERE WERE NO UNUSUAL FACTORS NOTED, NO EXCESSIVE SWEATING WAS OBSERVED. THE COIL WAS REMOVED FROM SERVICE AND WILL BE SENT BACK TO MANUFACTURER FOR FAILURE MODE TESTING.