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 Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

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 defibrillate a (b)(6) year old male patient, during cardioversion, an arc was seen from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the electrode pads were returned.Evaluation of the electrodes after removing the gel on both pads did reveal evidence that the pads were discharged during use.However, a heavy presence of hair and scaly skin was found on the foam adhesive of the electrodes.Retained samples were tested and yielded no discrepancies.The clinical data was not available as part of this investigation.Based on the evaluation of the electrode pads, the evidence suggests that this incident was related to poor coupling to the patient which is likely related to patient preparation.Zoll medical corporation instructs users to treat the patient's skin by clipping any excessive body hair that may compromise skin coupling.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: 7966689
• MDR Text Key: 123746291
• Report Number: 1220908-2018-03000
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017200
• UDI-Public: 00847946017200
• 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
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2017
• 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