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

Model Number 8900-4006

Device Problem Sparking (2595)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) male patient, a visible spark was seen emitted from the electrode pads.Complainant indicated that the patient suffered burns.The doctor checked on the patient following the procedure and the patient reported that he was fine.No additional wound consultation was required.

• 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
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 14414885
• MDR Text Key: 291820725
• Report Number: 1218058-2022-00046
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: 00847946016661
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male