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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 Arcing of Electrodes (2289); Sparking (2595)
Patient Problem Burn(s) (1757)
Event Type  Injury  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), arcing/sparking was seen coming from the electrode pads. Complainant alleged that the patient subsequently sustained a burn. The customer was unable to provide information on the degree of the burn.
 
Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed. The device was put through extensive testing which included bench handling, shock testing, and sync testing without duplicating the malfunction. Review of the device log did show multiple instances of pd core warning 247. However, this is not an indication of a device malfunction, but an advisory message for when the device is not recognizing a valid patient impedance. It's important to mention that the electrodes used during the time of the event were not returned for evaluation as part of the investigation. However, the images provided by the customer indicate the patient was not prepped properly before applying the electrodes. The device was recertified and returned to the customer. Analysis of reports of this type has not identified an increase in trend. Review of the activity logs did not find evidence to support the reported event.
 
Manufacturer Narrative
This report was inadvertently submitted under the incorrect facility against the associated defibrillator. Please refer to the submission on medwatch 1218058-2018-00083 for the correct facility/electrode pads.
 
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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 Key7931534
MDR Text Key122543822
Report Number1220908-2018-02861
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060559/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2018
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 Manufacturer09/19/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
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: 10/03/2018 Patient Sequence Number: 1
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