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

Model Number 8900-0224-01

Device Problem Arcing of Electrodes (2289)

Patient Problems Burn(s) (1757); Death (1802)

Event Type  Death  

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 defibrillate a male patient (age unknown), the electrode pads emitted sparks when delivering the fifth shock using the associated device.Complainant indicated that the patient received burns on the side of their head and ear.Complainant indicated that the patient subsequently expired, however they believe it was not a result of the reported malfunction.

Manufacturer Narrative

A set of electrodes were returned to zoll medical corporation.Evaluation of the electrodes revealed that there was excessive amounts of hair and skin particles stuck to the pads.It is suspected that the cause of the reported event is due to poor coupling of the electrode pads to the patient.The ifu states poor adherence and/or air under the electrode can lead to possibility of arcing and skin burns.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
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 7890230
• MDR Text Key: 120754692
• Report Number: 1218058-2018-00081
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/10/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death