MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP; DEFIB/PACING ELECTRODE

Model Number 8900-4005

Device Problem Arcing of Electrodes (2289)

Patient Problem No Information (3190)

Event Date 10/01/2020

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 spark was seen from the electrode pads while attached to the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The electrodes were returned to zoll medical corporation; evaluation of the electrodes revealed that there was some 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.Good skin preparation does not guarantee a burn will not occur and burns from defibrillation is an expected risk.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10680211
• MDR Text Key: 211365116
• Report Number: 1218058-2020-00080
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K960676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/18/2021
• Device Model Number: 8900-4005
• Device Catalogue Number: 8900-4005
• Device Lot Number: 2520B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1