inforMED
MalfunctionLWH

SITUATE

Received Jun 10, 2021 · Event occurred May 24, 2021

Report 11974234 · MDR key 11974234

Device

Generic name

Counter, Sponge, Surgical

Manufacturer

Covidien

Catalog number

01-0031

Lot number

42OR13683

Product problems

  • Protective Measures Problem

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

"FAULT: REPLACE ACCESSORY" WARNING WAS FOUND ON THE SITUATE MACHINE THIS MORNING. STAFF IN ROOM REPLACED PAD AND THE MACHINE GAVE THE GREEN LIGHT WITH THE NEW ACCESSORY. FAULTY PAD PLACED ON BIOMED REPAIR CART.