MAUDE Adverse Event Report: WESTMED, INC. EASY RESUSCITATOR AMBU BAG; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 562048

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  Injury  

Event Description

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.

• Brand Name: EASY RESUSCITATOR AMBU BAG
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): WESTMED, INC.
• MDR Report Key: 16610626
• MDR Text Key: 312023121
• Report Number: MW5115952
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 562048
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG