inforMED
MalfunctionCBL

MEDISORB

Received Mar 1, 2018 · Event occurred Feb 8, 2018

Report 7305736 · MDR key 7305736

Device

Generic name

Absorbent, Carbon-dioxide

Catalog number

M11173310

Lot number

171104-0101

Product problems

  • Crack

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Description of Event or Problem

WHEN SETTING UP FOR AN OPERATING ROOM CASE, ANESTHESIA FOUND A CRACK IN THE PLASTIC HOUSING UNDERNEATH THE ORANGE PROTECTIVE COVER OF A NEW CO2 MULTI-ABSORBER. THE DEVICE WAS NOT USE ON THE PATIENT. PER MANUFACTURER RESPONSE TO THE HOSPITAL. (B)(4) HAS SOLD THIS DIVISION TO VYAIRE.