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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORP. DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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ZOLL MEDICAL CORP. DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number R-SERIES
Device Problem No Display/Image (1183)
Patient Problems Coma (2417); Confusion/ Disorientation (2553); Loss Of Pulse (2562)
Event Date 10/01/2019
Event Type  Injury  
Event Description
At 0941 found pulseless and unresponsive. Code blue called. Defibrillator and pads applied. No display available on monitor. Second defibrillator attached to pads and monitor showed asystole. Prior to code, pt confused. After code coma. Cold calorics consistent with brain death.
 
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Brand NameDEFIBRILLATOR/MONITOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORP.
269 mill rd.
chelmsford MA 01824
MDR Report Key9180036
MDR Text Key162343105
Report NumberMW5090351
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
Type of Report Initial
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberR-SERIES
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/10/2019 Patient Sequence Number: 1
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