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 Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

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 cardiovert a patient (age & gender unknown), an arc was seen coming from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections d4 and h4.Evaluation: the electrode pads were returned to zoll medical corporation opened and adhered together.Visual inspection found faint burn marks on the conductive plate of the front and back pads indicating the occurrence of discharge.The electrodes were subjected to multiple shock tests at various joule settings with no discrepancies found.At no time during testing were sparks observed from the electrodes.Patient burns can be associated outcome with defibrillation events and is identified in labeling as an expected risk.Analysis of 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: 10350887
• MDR Text Key: 202014820
• Report Number: 1218058-2020-00057
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/07/2021
• Device Model Number: 8900-4005
• Device Catalogue Number: 8900-4005
• Device Lot Number: 1920B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1