inforMED
MalfunctionBTM

ADULT RESUSCITATION BAG, BAG RESEVOIR, LARGE ADULT MASK AND 7 FT OXYGEN TUBING A

Received Apr 2, 2024 · Event occurred Mar 21, 2024

Report MW5153493 · MDR key 19032927

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Model number

CPRM1116

Lot number

40022110033

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

WE (SIMULATION CENTER) RECEIVED AN AMBU BAG FROM LOGISTICS FOR OUR CODE CART AND WHEN STAFF WENT TO USE IT DURING A TRAINING DRILL ON 9A TO GIVE VENTILATIONS TO OUR MANNEQUIN WE NOTICED SOME DEFECTS AND DIFFICULTIES BEING ABLE TO PERFORM THAT TASK. THE AMBU BAG WAS MISSING THE ELBOW PIECE WHICH WOULD ALLOW THE MASK BE PERPENDICULAR TO THE BAG WHEN PERFORMING BREATHS. UNFORTUNATELY, WITHOUT THE PIECE THE BAG WAS VERTICAL TO THE MASK AND WOULD NOT ALLOW FOR EFFECTIVE VENTILATIONS. CONCERN IS WHETHER THIS SPECIFIC AMBU BAG SET-UP MAY HAVE BEEN DISTRIBUTED TO CODE CARTS WITHIN THE ORGANIZATION AND THIS WILL MAKE THE ROLE OF VENTILATOR DURING A MEDICAL EMERGENCY DIFFICULT TO PERFORM. THIS IS AN URGENT SAFETY ISSUE THAT NEEDS TO BE LOOKED INTO. LOCAL INVESTIGATION CONFIRMED ALL CODE CARTS DID NOT HAVE IMPACTED ITEMS.