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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL PRO PADZ (PACE AND DEFIB PADS) AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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ZOLL MEDICAL CORPORATION ZOLL PRO PADZ (PACE AND DEFIB PADS) AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number PACKAGING WAS NOT SAVED
Device Problem Excessive Heating (4030)
Patient Problem Burn, Thermal (2530)
Event Date 12/23/2020
Event Type  Injury  
Event Description
Defibrillation performed with zoll pro padz and patient received burn to anterior chest wall. Fda safety report id# (b)(4).
 
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Brand NameZOLL PRO PADZ (PACE AND DEFIB PADS)
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
MDR Report Key11108055
MDR Text Key225091540
Report NumberMW5098623
Device Sequence Number1
Product Code MKJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPACKAGING WAS NOT SAVED
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/31/2020 Patient Sequence Number: 1
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