inforMED
MalfunctionMOS

GE 1.5T GEM HNU

Received Oct 20, 2017 · Event occurred Aug 21, 2017

Report 6965176 · MDR key 6965176

Device

Generic name

Coil, Magnetic Resonance

Manufacturer

Ge Healthcare

Model number

1.5T GEM HNU

Catalog number

5372735

Product problems

  • Break

Patient

59 YR

  • No Information
  • No Information

Narrative

Description of Event or Problem

THE MRI MACHINE MALFUNCTIONED WHEN THE COIL BROKE MAKING UN-USABLE FOR PATIENT CARE. MANUFACTURER RESPONSE FOR MRI COIL, GE 1.5T GEM HNU (PER SITE REPORTER): FIELD REPRESENTATIVE TO SITE TO REPLACE MRI COIL. FIELD REPRESENTATIVE TOOK FAULTY COIL WITH HIM AFTER REPLACEMENT.