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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL R SERIES DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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ZOLL MEDICAL CORPORATION ZOLL R SERIES DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number R SERIES
Device Problem Sparking (2595)
Patient Problem Insufficient Information (4580)
Event Date 07/14/2021
Event Type  No Answer Provided  
Event Description
During a cardiac arrest in the ir unit where he was getting an entec placed, the zoll defibrillator sparked from the defib pads on the chest. Fda safety report id# (b)(4).
 
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Brand NameZOLL R SERIES DEFIBRILLATOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
MDR Report Key12238689
MDR Text Key264064642
Report NumberMW5102795
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 07/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberR SERIES
Device Catalogue Number601064903
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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