MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE; DEFIB/PACING ELECTRODE

Model Number 8900-4006

Device Problem Arcing of Electrodes (2289)

Patient Problem No Information (3190)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the device and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while defibrillating a (b)(6) -year-old male patient, an arc was seen from the electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was evaluated by zoll medical corporation.Inspection of the returned pro padz did not find any evidence of an arc point or burn marks that occured during the reported event.The gel was removed from the conductive plates for further evlauation which yielded no discrepancies.The pads were scrapped.An abundance of hair was observed attached to the electrode pads which suggests patient prep was not performed in accordance which zoll recommendations.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8728831
• MDR Text Key: 149084225
• Report Number: 1218058-2019-00073
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: 00847946016661
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/22/2020
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 1719A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR