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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
Catalog Number 8900-4006
Device Problems Sparking (2595); Noise, Audible (3273)
Patient Problem Burn, Thermal (2530)
Event Date 08/28/2019
Event Type  Injury  
Event Description
During cardioversion shock, a popping sound and visible spark was seen on the chest pad. The pt had two semicircular burns found underneath the chest pad, no burns underneath the back pad. The cardioversion was successful. Fda safety report id# (b)(4).
 
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Brand NamePRO-PADZ
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA 01824
MDR Report Key9134730
MDR Text Key160677238
Report NumberMW5090097
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 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/18/2020
Device Catalogue Number8900-4006
Device Lot Number2019A
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: 09/27/2019 Patient Sequence Number: 1
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