inforMED
InjuryCBL

MEDISORB EF MULTI-ABSORBER, DISPOSABLE

Received Mar 18, 2020 · Event occurred Jan 1, 2020

Report 3002807637-2020-00002 · MDR key 9849713

Device

Generic name

Co2 Absorbers

Manufacturer

Vyaire Medical

Catalog number

M1173311

Product problems

  • Moisture or Humidity Problem
  • Moisture or Humidity Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

AS OF NOW, SAMPLES HAVE NOT BEEN RETURNED FOR EVALUATION. THERE ARE FOUR(4) LOT NUMBERS AFFECTED: 7961019, 4990819, 5120819 AND 8291019. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE M1173311 MEDISORB EF MULTI-ABSORBER, DISPOSABLE GRANULES IN CANNISTERS ARE NOT ALLOWING WATER/MOISTURE TO DESCEND DOWN INTO THE CANISTER. NO HARM REPORTED TO THE PATIENT.