EASY RESUSCITATOR AMBU BAG
Received Mar 23, 2023 · Event occurred Mar 14, 2023
Report MW5115952 · MDR key 16610626
Device
Product problems
- Fluid/Blood Leak
- Tear, Rip or Hole in Device Packaging
- Detachment of Device or Device Component
Patient
63 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORTED FAILURE OF MANUAL SELF-INFLATING RESUSCITATION BAG DEVICE ("AMBU BAG") DURING LARYNGOSCOPY. ANESTHESIA NOTED HIGH PRESSURE TO VENTILATE A PATIENT UNDER GENERAL ANESTHESIA, AFTER INTUBATION. ANESTHESIA SWITCHED TO MANUAL RESUSCITATION WITH CONTINUED DECREASE IN OXYGEN LEVELS. SUBSEQUENT RESPIRATORY AND CARDIAC ARREST. ATTENDING SURGEON PERFORMED EMERGENT TRACHEOSTOMY INCISION, CONFIRMED ENDOTRACHEAL TUBE IN PLACE, AND DID NOT COMPLETE INSERTION OF TRACHEOSTOMY. DIFFERENT BRAND OF RESUSCITATION BAG OBTAINED AND OXYGEN SATURATION RECOVERED. AFTER RETURN OF SPONTANEOUS CIRCULATION, SURGERY ABORTED AND PATIENT ADMITTED TO INTENSIVE CARE UNIT. UPON REVIEW, PREVIOUS EPISODE OF FAILURE OF SELF-INFLATING RESUSCITATION BAG DEVICE (WEST MED BAG EASY RESUSCITATOR REF 562048) IN (B)(6) 2022 AFTER EVENT IN EMERGENCY DEPARTMENT WITH SEVERAL BAGS USED DURING CODE EVENT. FAILURE APPEARS TO BE WHEN BAG IS PULLED FROM THE MOUTHPIECE DURING PREPARATION, CAUSING A LEAK IN THE FLANGE BETWEEN THE HARD PLASTIC MOUTHPIECE AND SOFT BAG PORTION. THIS MAY BE A DISCONNECT OR TEAR IN THE RESERVOIR BAG OR SEAL.