inforMED
MalfunctionBTM

AIRFLOW PEDIATRIC RESUSCITATOR

Received Nov 25, 2024 · Event occurred Aug 9, 2024

Report 20770906 · MDR key 20770906

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Model number

AF2142MB

Lot number

408817

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

RESPIRATORY THERAPIST (RT) REPORTS RESUSCITATION BAG WITH PEEP VALVE WAS UNABLE TO MAINTAIN PEEP DESPITE APPROPRIATE PEEP SETTING ON THE PEEP VALVE. RT OBTAINED ANOTHER PEEP VALVE TO ENSURE IT WAS THE RESUSCITATION DEVICE AND NOT THE PEEP VALVE. THE RESUSCITATION BAG WOULD NOT HOLD PEEP WITH ANY PEEP VALVE.