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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORPORATION PRO-PADZ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 8900-4006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 12/19/2018
Event Type  malfunction  
Event Description
Patient was cardioverted and pads were removed. Patient converted back into a atrial fib and new pads were placed and the patient was cardioverted again. When removing the pads the second time it was noted that the patient was burnt and the patient had a burnt smell.
 
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Brand NamePRO-PADZ
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill rd
chelmsford MA 01824 4105
MDR Report Key8217374
MDR Text Key132342387
Report NumberMW5082833
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 12/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/24/2019
Device Model Number8900-4006
Device Catalogue Number00847946016661
Device Lot Number4718A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

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