MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE

Model Number 8900-0224-01

Device Problems Arcing of Electrodes (2289); Sparking (2595)

Patient Problem No Information (3190)

Event Date 12/08/2019

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 patient (age & gender unknown), a sparking/arcing was seen coming from these electrode pads.Complainant indicated that the clinician obtained another set of electrode pads which were not used to shock since the first set of pads used converted the patient's heart rhythm successfully.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Two sets of one step cpr complete electrode pads were returned to zoll medical corporation for evaluation.The first set of electrodes lot 3519d were inspected and showed evidence of being applied to a patient, however showed no indications of arcing.This set of electrodes correlates with the customer's report of being the second set of pads that were not used to shock the patient.The other set of electrode pads were lot 3519a and this set had been previously stuck together and sustained some damage when separated for review.A visual inspection showed a burn on the rim of the conductor plate on the anterior pad indicating that a discharge occurred.There were also several large creases.These observations indicate poor contact between the electrode pads and the patient's skin.Our electrode labeling calls out the importance of good placement on the patient and provides instructions for proper electrode application technique.Poor adherence and/or air under the electrodes can lead to the possibility of arcing and skin burns.Burns from defibrillation is an expected risk and good skin preparation does not guarantee a burn will not occur.Both sets of electrode pads were scrapped.This claim has been closed as poor patient coupling.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP COMPLETE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9531631
• MDR Text Key: 177807500
• Report Number: 1218058-2019-00180
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1