VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH
Received Sep 10, 2013 · Event occurred Aug 20, 2013
Report 3005748597-2013-00002 · MDR key 3358294
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Electric Shock
- Superficial (First Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
SYSTEM HAS BEEN IN USE FOR MORE THAN 4 YEARS WITH THIS BEING THE FIRST REPORT OF PT RECEIVING BLISTERS, USING THE AFFECTED SYSTEM. SENTINELLE FIELD ENGINEER (FE) WENT ON SITE TO INVESTIGATE AFFECTED SYSTEM. FE PERFORMED INSPECTIONS AND TESTING AND REPORTED THAT SYSTEM WAS PERFORMING/FUNCTIONING AS EXPECTED. NO CAUSAL EFFECT CAN BE DETERMINED BETWEEN THE ADVERSE EVENT (BLISTERING) AND THE FAILURE OF THE DEVICE.
Description of Event or Problem
PT RECEIVED TWO (2) MILD WHITE BLISTERS (SURROUNDED BY REDNESS) ON BOTH THUMB'S DURING A BREAST MRI EXAM. PT REPORTED FEELING AN ELECTRICAL SENSATION RUNNING THROUGH HER BODY DURING A BREAST MRI SCAN. WHEN EXAMINED BY THE RADIOLOGIST TWO SMALL AREAS OF MILD BLISTERING WERE NOTED ON THE PT'S LEFT AND RIGHT THUMB. SITE REPORTED THAT DUE TO LARGE SIZE OF BREASTS, A HIGHER FIELD OF VIEW (FOV) AND INCREASE IN NUMBER OF SLICES WAS REQUIRED. PT DID NOT REQUIRE INTERVENTION OR TREATMENT FOR BLISTERING.