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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORP ZOLL PRO PADZ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 8900-4006
Device Problem Excessive Heating (4030)
Patient Problem Burn, Thermal (2530)
Event Date 11/18/2020
Event Type  Injury  
Event Description
Patient received burn when zoll pro padz used during cardioversion. Fda safety report id # (b)(4).
 
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Brand NameZOLL PRO PADZ
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORP
chelsford ME 01824
MDR Report Key11108086
MDR Text Key225090985
Report NumberMW5098627
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 Expiration Date10/17/2021
Device Model Number8900-4006
Device Lot Number4220
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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