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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORPORATION ZOLL AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 09/28/2020
Event Type  malfunction  
Event Description
Turned on zoll before cardioversion and the machine charged and delivered shock to patient before we were ready.
 
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Brand NameZOLL
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key10711269
MDR Text Key212311208
Report Number10711269
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/01/2020
Event Location Hospital
Date Report to Manufacturer10/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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