inforMED
MalfunctionGWE

NATUS PHOTIC STIM KIT

Received Nov 15, 2018 · Event occurred Feb 13, 2016

Report 9612330-2018-00018 · MDR key 8074454

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 MECHANICAL MOVEMENT.

Description of Event or Problem

DURING PHOTIC ACTIVATION THE POWER CABLE STARTING SPARKING. PHOTIC POWER CABLE HAD EXPOSED WIRES AFTER SPARKS OCCURED. NO ONE WAS HURT.

Remedial action

  • Replace