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

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.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 7931534
• MDR Text Key: 122543822
• Report Number: 1220908-2018-02861
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017521
• UDI-Public: 00847946017521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• 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 Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other