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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORPORATION R SERIES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number R SERIES ALS
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)
Patient Problems Cardiac Arrest (1762); Electric Shock (2554)
Event Date 09/25/2020
Event Type  Injury  
Event Description
The patient was noted to have an acute change in mental status and new left-sided weakness. Code stroke initiated, patient connected to zoll r series defibrillator with pads for continuous monitoring. The patient was transported to ct (computed tomography) with the defibrillator. The patient returned to the room following cta (computed tomography angiography) and the defibrillator was plugged into the wall. The monitor screen of the defibrillator began flashing a battery fault message although the device was plugged into an electrical outlet. The defibrillator was unplugged and plugged into a different electrical outlet, the battery fault message continued. Troubleshooting continued by activating a defibrillator check and the patient was inadvertently shocked with 35. 8 joules. The patient suffered a cardiac arrest as a result of the shock. Cpr was immediately initiated. The patient was intubated and there was return of circulation after three rounds of cpr. The patient was transferred to icu. Suggest the manufacturer update equipment to advise the operator if a shock is not advised based on the rhythms. Manufacturer response for defibrillator, zoll r series defibrillator (per site reporter). Zoll replaced the internal battery, ecg isolator, ecg shields, and lcd cable. The device passed all final system-level tests.
 
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Brand NameR SERIES
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key11265312
MDR Text Key229866195
Report Number11265312
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 01/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberR SERIES ALS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/31/2021
Event Location Hospital
Date Report to Manufacturer02/02/2021
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

Patient Treatment Data
Date Received: 02/02/2021 Patient Sequence Number: 1
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