inforMED
MalfunctionMOS

UNKNOWN

Received Dec 16, 2010 · Event occurred Mar 17, 2009

Report 2183553-2010-00054 · MDR key 1960395

Device

Generic name

Unknown

Model number

2218111

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A REVIEW OF GE HEALTHCARE SERVICE RECORDS SHOWS THAT THE BRM RF COIL OF THIS GE HEALTHCARE MR SYSTEM WAS REPLACED AND RETURNED TO THE MFG SITE FOR REPAIR. INITIAL EVAL REVEALED THAT THE BRM RF COIL MAY HAVE BEEN SUBJECT TO A THERMAL EVENT. NO INJURY WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.