MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP; DEFIB/PACING ELECTRODE

Model Number 8900-4005

Device Problems Accessory Incompatible (1004); Arcing of Electrodes (2289)

Patient Problem Burn(s) (1757)

Event Date 08/25/2021

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 an (b)(6) male patient, an arc was heard from the electrode pads.Complainant indicated that the patient subsequently sustained a burn.The degree of burn has not been provided.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b1, b5, and h1.Device investigation: the customer was contacted for return of the suspect product.The customer has responded and indicated the product will not be returning to zoll.

Event Description

Complainant alleged that while attempting to cardiovert an 89-year-old male patient, an arc was heard from the electrode pads.Complainant indicated that the patient subsequently sustained a 1st degree burn.

• 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: 12422753
• MDR Text Key: 270499489
• Report Number: 1218058-2021-00118
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/26/2022
• Device Model Number: 8900-4005
• Device Catalogue Number: 8900-4005
• Device Lot Number: 0921A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR