inforMED
MalfunctionMOS

GE

Received Jan 11, 2017 · Event occurred Dec 31, 2016

Report MW5067195 · MDR key 6249083

Device

Generic name

Anterior Array Coil

Manufacturer

Ge

Product problems

  • Device Operates Differently Than Expected

Patient

50 YR

  • Swelling
  • Swelling

Narrative

Description of Event or Problem

PT PRESENTED WITH BILATERAL BLISTER ON INNER THIGH POST MRI OF LOWER EXTREMITY. PER PT'S PHYSICIAN THE BLISTERS WERE SMALL AND DID NOT REQUIRE TREATMENT, NO BURN CREAM WAS ADMINISTERED. MRI SAFETY OFFICER/ PHYSICIST (B)(6) CAME OUT AS DID GE FIELD SERVICE ENGINEER TO INVESTIGATE ON 01/04/2017. THE COIL WAS TAKEN OUT OF USE ON (B)(6) 2017 WHEN THE PT'S PHYSICIAN ALERTED MR OF THE INCIDENT.