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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WESTMED INC. BAG EASY RESUSCITATOR

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WESTMED INC. BAG EASY RESUSCITATOR Back to Search Results
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.
 
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Brand NameBAG EASY RESUSCITATOR
Type of DeviceBAG EASY RESUSCITATOR
Manufacturer (Section D)
WESTMED INC.
MDR Report Key7537292
MDR Text Key109037964
Report NumberMW5077413
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number033018U15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/23/2018 Patient Sequence Number: 1
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