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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL R SERIES DEFIBRILLATORS ALS AUTOMATED EXTERNAL DEFIBRILLATORS

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ZOLL MEDICAL CORPORATION ZOLL R SERIES DEFIBRILLATORS ALS AUTOMATED EXTERNAL DEFIBRILLATORS Back to Search Results
Device Problem Failure to Deliver Shock/Stimulation (1133)
Patient Problems Death (1802); Loss Of Pulse (2562)
Event Date 03/10/2020
Event Type  malfunction  
Event Description
Zoll was charged and shock button was pressed, however no visible shock delivered to pt. Pads changed and attempted to shock pt again, again no noticeable shock delivered to pt. New zoll was noticeable shock delivered to pt. Pt arrived in asystole, post car accident into a river, found approx 30 mins later in cardiac, drowning listed as cause of death. Fda safety report id# (b)(4).
 
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Brand NameZOLL R SERIES DEFIBRILLATORS ALS
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
MDR Report Key9834691
MDR Text Key183875563
Report NumberMW5093747
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 Other Health Care Professional
Type of Report Initial
Report Date 03/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/11/2020
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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