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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER

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ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number R SERIES
Device Problems Defibrillation/Stimulation Problem (1573); Sparking (2595); Patient Device Interaction Problem (4001)
Patient Problem Burn(s) (1757)
Event Date 11/12/2019
Event Type  Injury  
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device's defib output was out of specification and sparks were seen. After removing the electrode pads, a burn was found on the patient. Patient sustained burnmarks.
 
Manufacturer Narrative
The device and electrode pads were returned to zoll medical. The device was put through extensive testing which included functional testing without duplicating the customer's report. The electrodes were returned used (stuck to each other with no styrene liners present) and without the original packaging. A heavy presence of hair was found on the foam adhesive of the electrodes. After review of photo's provided by the customer shows the patient was not prepped and had a circular burn mark in the middle of the chest. Zoll recommends that patients are cleaned and clipped prior to applying electrode pads to assure good coupling of electrode to skin contact. This investigation was closed as improper patient preparation prior to the application of the electrodes. Analysis for reports of this type has not identified an increase in trend.
 
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Brand NameR SERIES DEFIBRILLATOR
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key9366816
MDR Text Key167759295
Report Number1220908-2019-03726
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K060559/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberR SERIES
Device Catalogue NumberR SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/23/2019 Patient Sequence Number: 1
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