inforMED
MalfunctionMUH

SCANX IO

Received Aug 13, 2018 · Event occurred Jul 12, 2018

Report 2428225-2018-00004 · MDR key 7776792

Device

Generic name

Scanx Io

Model number

B7100C

Product problems

  • Fire
  • Arcing
  • Lack of Maintenance Documentation or Guidelines
  • Fire
  • Arcing
  • Lack of Maintenance Documentation or Guidelines

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

CUSTOMER REPORTED FLAMES COMING FROM THE EXTERNAL POWER. CUSTOMER WAS PREPARING TO PROCESS IMAGES WHEN THE INCIDENT OCCURRED. TRANSPORT WAS NOT YET ACTIVATED AND THE UNIT WAS IDLE WHEN SHE STATED SHE SAW FLAMES COMING FROM THE EXTERNAL POWER SUPPLY. PER THE CUSTOMER THERE WAS NO ELECTRICAL STORM OR CONSTRUCTION IN THE NEARBY VICINITY. THERE WERE NO REPORTS OF INJURY. NO EMERGENCY SERVICES WERE CONTACTED.

Additional Manufacturer Narrative

A DEVICE WAS SENT FOR FURTHER EVALUATION TO DETERMINE THE ROOT CAUSE.

Description of Event or Problem

CUSTOMER REPORTED FLAMES COMING FROM THE EXTERNAL POWER. CUSTOMER WAS PREPARING TO PROCESS IMAGES WHEN THE INCIDENT OCCURRED. TRANSPORT WAS NOT YET ACTIVATED AND THE UNIT WAS IDLE WHEN SHE STATED SHE SAW FLAMES COMING FROM THE EXTERNAL POWER SUPPLY. PER THE CUSTOMER THERE WAS NO ELECTRICAL STORM OR CONSTRUCTION IN THE NEARBY VICINITY. THERE WERE NO REPORTS OF INJURY. NO EMERGENCY SERVICES WERE CONTACTED.

Remedial action

  • Other