inforMED
MalfunctionGWE

PHOTIC STIM

Received Nov 28, 2018 · Event occurred Aug 27, 2015

Report 9612330-2018-00022 · MDR key 8110329

Device

Generic name

Photic Stimulator

Product problems

  • Electrical /Electronic Property Problem
  • Sparking
  • Electrical /Electronic Property Problem
  • Sparking

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

FOLLOWING NATUS COMPLAINT PROCEDURE, THE PHOTIC SYSTEM WAS INVESTIGATED. THE CABLE FOUND BROKEN AT THE END OF LOWER ARM. NORMAL WEAR AND TEAR FAILURE DUE TO THE MECHANICAL MOVEMENT. REPLACEMENT DEVICE PROVIDED TO THE CUSTOMER.

Description of Event or Problem

SPARK WAS OBSERVED ON PHOTIC DEVICE. POWER CORD WAS FOUND DAMAGED UPON INSPECTION OF THE DEVICE, INCIDENT HAS NO EFFECT ON PATIENT/USER SAFETY.

Remedial action

  • Replace