inforMED
MalfunctionPLA

ENSOETM

Received Apr 4, 2023 · Event occurred Mar 23, 2023

Report 16673099 · MDR key 16673099

Device

Generic name

Esophageal Thermal Regulation And Gastric Suctioning Device

Manufacturer

Attune Medical

Model number

ECD04-A

Lot number

199207722

Product problems

  • Material Split, Cut or Torn

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

ENTERAL PORT WITH TEAR AT BIFURCATION WITH COOLING LUMENS.