inforMED
MalfunctionDPZ

SENTEC V-SIGN

Received Apr 27, 2018 · Event occurred Jan 3, 2018

Report 7468483 · MDR key 7468483

Device

Generic name

Oximeter, Ear

Manufacturer

Imagenix, Inc

Model number

SDMS

Product problems

  • Device Operates Differently Than Expected

Patient

0 YR

  • No Information
  • No Information

Narrative

Description of Event or Problem

THE SENTEC SENSOR INSULATION IS PRONE TO CRACKING AND EXPOSING LARGE GAPS THAT MAKE IT IMPOSSIBLE TO DISINFECT. THOUGH THE SENSOR IS OPERATIONAL IT CANNOT BE USED SINCE IT CANNOT BE CLEANED PROPERLY.