inforMED
MalfunctionCAN

MEDICA CARBON DIOXIDE REGULATOR

Received May 4, 2020 · Event occurred Feb 9, 2020

Report 10020241 · MDR key 10020241

Device

Generic name

Regulator, Pressure, Gas Cylinder

Model number

M1-940-PG

Catalog number

M1-940-PG

Product problems

  • Defective Component

Patient

0 DA

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WHEN CHANGING CIRCUIT, ELEVATED CO2 NOTED, AND WOULD NOT COME DOWN UNTIL CO2 REGULATOR WAS CHANGED. MEDICA CARBON DIOXIDE REGULATOR. EQUIPMENT REMOVED FROM ECMO PUMP AND REPLACED WITH ANOTHER REGULATOR. INFANT HAD A SCHEDULED HEAD ULTRASOUND AFTER THE INCIDENT WHICH SHOWED NO CHANGE.