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

Model Number R SERIES

Device Problem Arcing of Electrodes (2289)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to cardiovert a (b)(6) male patient, an arc was seen coming from the electrode pads when a shock was delivered.Complainant indicated the patient was successfully cardioverted to a sinus rhythm.

Manufacturer Narrative

The electrodes were returned for evaluation.Evaluation of the electrodes did reveal energy concentration spots on the conductive pads; however, a heavy presence of hair was found on the foam adhesive of the electrodes.This evaluation concluded that the cause of the reported problem was due to improper skin preparations.The instructions for use indicate to remove excess chest hair to maximize gel to skin contact and warns that excessive hair, scaly skin and debris can inhibit good coupling which can lead to the possibility of arcing and skin burns.This claim has been closed as poor patient preparation.Analysis for reports of this type has not identified an increase in trend.Analysis of reports of this type has not identified an increase in trend.

• 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: 5976710
• MDR Text Key: 55620021
• Report Number: 1220908-2016-02317
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Device Lot Number: N/A
• Other Device ID Number: 00847946017163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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 Age: 60 YR