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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORPORATION ZOLL ELECTRODE PADS AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number PRO-PADS REF 8900-4006
Device Problems Device Emits Odor (1425); Sparking (2595); Excessive Heating (4030)
Patient Problem Burn, Thermal (2530)
Event Date 01/22/2021
Event Type  Injury  
Event Description
Pt hooked up to zoll monitor; protocol followed for cardioversion. Shocked x1 at 200 joules. With the deliverance of this shock, a spark was seen and a loud "pop" was heard, followed by a burning smell. The patient was immediately checked for complications and a burn was noticed underneath the anterior defibrillator pad on his chest. Fda safety report id#: (b)(4).
 
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Brand NameZOLL ELECTRODE PADS
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
MDR Report Key11243432
MDR Text Key229646000
Report NumberMW5099050
Device Sequence Number1
Product Code MKJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPRO-PADS REF 8900-4006
Device Catalogue NumberNOT AVAILABLE
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

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