InjuryBTM
VITAL SIGNS
Received Oct 18, 2021 · Event occurred Sep 12, 2021
Report 12646685 · MDR key 12646685
Device
Product problems
- Increase in Pressure
- Structural Problem
Patient
Not reported
- Unspecified Tissue Injury
- Unspecified Tissue Injury
Narrative
Description of Event or Problem
WE HAD A SERIOUS SAFETY EVENT IN OUR PEDIATRIC ICU THAT INVOLVED THE USE OF A FLOW-INFLATING MANUAL RESUSCITATOR BAG. THE PRESSURE RELEASE VALVE WAS LEFT CLOSED WHILE GIVING BREATHS, CAUSING HIGH PRESSURES TO ENTER THE LUNGS WHICH RESULTED IN INJURY TO THE PATIENT. MANUFACTURER RESPONSE FOR BREATHING CIRCUIT, JACKSON REES BREATHING CIRCUIT (PER SITE REPORTER): ALERTED THE MANUFACTURER, PROVIDED THE MEDSUN REPORT NUMBER AND THE DETAILS OF THE EVENT THAT THEY REQUESTED.