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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORP. ZOLL ONE STEP CPR COMPLETE, CPR PAD AUTOMATED EXTERNAL DEFIBRILLATOR (NON-WEARABLE)

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ZOLL MEDICAL CORP. ZOLL ONE STEP CPR COMPLETE, CPR PAD AUTOMATED EXTERNAL DEFIBRILLATOR (NON-WEARABLE) Back to Search Results
Device Problem Sparking (2595)
Patient Problem Burn, Thermal (2530)
Event Date 09/25/2018
Event Type  Injury  
Event Description
During code, defibrillator pad in placed for shock at 200 joules. Shock delivered. Sparks, burning, and loud pop noted from defibrillator. A pad shaped burn noted on patient's chest.
 
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Brand NameZOLL ONE STEP CPR COMPLETE, CPR PAD
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORP.
chelmsford MA 01824
MDR Report Key7930074
MDR Text Key122815075
Report NumberMW5080314
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/02/2018 Patient Sequence Number: 1
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