MAUDE Adverse Event Report: WESTMED INC. BAG EASY RESUSCITATOR

Lot Number 033018U15

Device Problems Arcing at Paddles (1032); Fire (1245)

Patient Problem Burn, Thermal (2530)

Event Date 05/08/2018

Event Type  Injury  

Event Description

The pt was being resuscitated.During defibrillation, the defib pads arched creating a spark.The spark ignited the resuscitation (ambu) bag and caused a fire.The staff quickly removed the product from the pt to the floor and put out the fire.This created burns to the pt's right chest/arm and face.Event abated after use stopped or dose reduced: yes.

• Brand Name: BAG EASY RESUSCITATOR
• Type of Device: BAG EASY RESUSCITATOR
• Manufacturer (Section D): WESTMED INC.
• MDR Report Key: 7537292
• MDR Text Key: 109037964
• Report Number: MW5077413
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/21/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 033018U15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR