inforMED
InjuryBTM

SPUR II INFANT

Received Nov 4, 2022 · Event occurred Oct 7, 2022

Report 1220828-2022-00014 · MDR key 15725552

Device

Generic name

Manual Emergency Ventilator

Manufacturer

Ambu A/s

Model number

335009000

Catalog number

335009000

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

Unknown

  • Hypoxia
  • Hypoxia

Narrative

Description of Event or Problem

THE CHILD (B)(6) WAS IN A VERY SERIOUS STATE (BRONCHOSPASM), UNDER NON-INVASIVE VENTILATION. UPON ARRIVAL, RESUSCITATION WITH SPUR II RESUSCITATOR WAS INITIATED. THE SPUR PRESENTED LEAKS AROUND THE CONNECTION WITH THE FACEMASK. AS A RESULT THE INFANT HAD TO BE INTUBATED.