TOSHIBA

Description of Event or Problem

A PATIENT ALLEGEDLY SUSTAINED TWO QUARTER-SIZED AREAS OF REDNESS AND TENDERNESS BILATERALLY AT THE ANTERIOR, SUPERIOR SPINE DURING AN MRI SCAN.

Additional Manufacturer Narrative

THE COIL WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. IT WAS DETERMINED THAT THE CAUSE OF THE PROBLEM WAS DAMAGE TO THE ANTERIOR CONNECTOR OF THE COIL. IT IS BELIEVED THAT THE DAMAGE TO THE ANTERIOR CONNECTOR CAUSED THE FEET SCAN OF THE COIL TO NOT MEET THE SNR SPECIFICATION. THIS IN TURN CAUSED THE SURFACE TEMPERATURE OF THE COIL TO RISE, CAUSING THE BURN TO THE PATIENT.

Additional Manufacturer Narrative

A PATIENT WAS SCANNED FOR A PELVIS AND LOWER EXTREMITY, THIGH TO KNEE IN A TOSHIBA MRI SYSTEM USING A QD TORSO SPEEDER COIL. ALLEGEDLY THE PATIENT COMPLAINED OF A WARMING SENSATION IN HER PELVIC REGION WHEN CONTRAST WAS INJECTED. THE PATIENT ALLEGEDLY SUSTAINED TWO QUARTER-SIZED AREAS OF REDNESS AND TENDERNESS BILATERALLY AT THE AREA OF THE ANTERIOR, SUPERIOR SPINE. THE PATIENT WAS EXAMINED BY A PHYSICIAN AND AN RN AND NO BLISTERING WAS SEEN. FOLLOW-UP CALLS WERE PLACED TO THE PATIENT AT 6 AND 24 HOURS LATER. AT 6 HOURS NO WORSENING AND AT 24 HOURS THE PATIENT INDICATED THAT THE TENDERNESS WAS GONE AND REDNESS WAS SLOWLY DISSIPATING. THE COIL WAS INSPECTED ONE DAY FOLLOWING THE SCAN AND NO PHYSICAL DAMAGE WAS NOTED. QA SCANS FOR THE COIL WERE PERFORMED AND IT DID NOT MEET ONE OF THE SPECIFICATIONS BUT IS NOT RELATED TO THE EVENT. THE COIL IS BEING REPLACED FOR THE CUSTOMER AND THE ORIGINAL COIL IS BEING RETURNED TO THE MANUFACTURER.