inforMED
MalfunctionOBN

RESPIRATORY GAS HUMIDIFIER

Received Oct 22, 2021

Report 3012307300-2021-10184 · MDR key 12684248

Device

Generic name

Respiratory Gas Humidifier

Product problems

  • Defective Device
  • Defective Device

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A PEEP PROBLEM. DEPENDING ON HOW THE PARAPAC WAS PLACED THE PEEP WOULD OR WOULDNT WORK. WHEN DEVICE PLACED ON BACK, THE MAX LEVEL OF PEEP WAS 13 CMH2O.