inforMED
MalfunctionBTM

AMBU SPUR II

Received May 31, 2024 · Event occurred May 25, 2024

Report MW5155681 · MDR key 19449177

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Manufacturer

Ambu A/s

Lot number

1000919409

Patient

70 YR · Male

  • Cardiac Arrest
  • Cardiac Arrest

Narrative

Description of Event or Problem

DURING THE COURSE OF CARDIAC ARREST RESUSCITATION, THE BAG PORTION OF THE BAG VALVE MASK ASSEMBLY FAILED TO RE-INFLATE. UPON ARRIVAL AT THE HOSPITAL A MEMBER OF THE EMERGENCY DEPARTMENT STAFF LOCATED A SEPARATION IN OR CRACK IN THE RUBBER BAG.