inforMED
MalfunctionBTM

AMBU SPUR II ADULT RESUSCITATOR SINGLE PATIENT USE RESUSCITATOR

Received Jul 13, 2023 · Event occurred Jun 9, 2023

Report 17315711 · MDR key 17315711

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Manufacturer

Ambu A/s

Lot number

1000804646

Product problems

  • Inflation Problem
  • Output Problem

Patient

26645 DA · Male

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

Narrative

Description of Event or Problem

AMBU BAG DID NOT WORK DURING AN INTUBATION. OXYGEN WAS FLOWING, RESERVOIR DID INITIALLY INFLATE, BUT WOULD NOT STAY INFLATED AND DID NOT DELIVER OXYGEN TO PATIENT. WHEN ATTEMPTING TO DELIVER A BREATH, THE AMBU BAG ITSELF HAD NO PRESSURE WHEN SQUEEZED. IT WOULD JUST DEFLATE. ALL CONNECTIONS WERE CHECKED AND WERE INTACT. QUICKLY OPENED A SECOND BAG AND THE SAME THING HAPPENED. THIRD BAG WAS OPERATIONAL.