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 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 defibrillating a patient (age & gender unknown), spark/arc was heard 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 complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.

• 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: 8781046
• MDR Text Key: 150729211
• Report Number: 1218058-2019-00080
• 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
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/12/2020
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 0719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1