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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
Device Problem Failure to Capture (1081)
Patient Problems Dizziness (2194); Diminished Pulse Pressure (2606)
Event Date 03/26/2021
Event Type  Injury  
Event Description
Attempted transcutaneous pacing using zoll one step cpr complete pads and r series. Unable to obtain capture. Pt's heart rate 30s, symptomatic: dizzy, pacer rate set at 70bpm, mas attempted between 40 and 80 mas with no visible electronic capture, no change in natural monitored heart rate or palpated pulse rate, and no physical signs or symptomatic of capture. Unsuccessful troubleshooting: checked cable and pad placement (used roll technique). R-series on pace mode (green) and plugged in. Replaced pad cable. Added electrode placement (and changed cord), pt given atropine with favorable response and transferred to (b)(6). Further testing completed on test boxes and manikin with more than one r-series producing varied inconsistent results. Unpredictable intermittent capture. Highly positionally dependent results.
 
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Brand NameR SERIES
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill rd
chelmsford MA 01824 4105
MDR Report Key11731419
MDR Text Key247695102
Report NumberMW5100984
Device Sequence Number8
Product Code MKJ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 04/06/2021
9 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9  
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

Patient Treatment Data
Date Received: 04/26/2021 Patient Sequence Number: 1
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