inforMED
InjuryBTM

WESTMED LLC

Received Apr 27, 2023 · Event occurred Mar 14, 2023

Report 2028807-2023-00013 · MDR key 16824695

Device

Generic name

Adult Bageasy, Resuscitator, W/peep And Mask

Manufacturer

Westmed Llc

Model number

562048

Catalog number

562048

Lot number

UNKNOWN

Product problems

  • Fluid/Blood Leak
  • Tear, Rip or Hole in Device Packaging
  • Detachment of Device or Device Component
  • Fluid/Blood Leak
  • Tear, Rip or Hole in Device Packaging
  • Detachment of Device or Device Component

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

REPORTABLE AS MANUAL RESUSCITATION FAILED TO PROVIDE ADEQUATE VENTILATION. COMPLAINT WAS CONFIRMED. ROOT CAUSE COULD NOT BE DETERMINED FOR IF THE COMPLAINT WAS DUE TO ASSEMBLY ERROR OR HANDLING ERROR WHEN DEVICE WAS BEING PREPPED FOR USE. INVENTORY COULD NOT REPEAT THE REPORTED DEFECT; HOWEVER, AN ADDITIONAL INSPECTION WAS CREATED TO ENSURE PRODUCT MAINTAINS PULL FORCE CONSISTENCY.

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 (B)(4)) 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.

Additional Manufacturer Narrative

REPORTABLE AS MANUAL RESUSCITATION FAILED TO PROVIDE ADEQUATE VENTILATION.

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 (B)(4)) 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.