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

Model Number 8900-4006

Device Problems Sparking (2595); Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 11/15/2019

Event Type  Injury  

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 cartioverting a male patient (age unknown), they observed a spark and then heard an arc from the electrode pads.After removing the electrode pads, burns were found on the patient.Patient sustained burn marks.The customer was unable to provide what degree burn the patient received.

Manufacturer Narrative

The customer was contacted for return of the suspect product.The product 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: 9469041
• MDR Text Key: 170860422
• Report Number: 1218058-2019-00170
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/10/2020
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 3219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other