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

Model Number	8900-2106-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that after a cardioversion on a 63-year-old male patient, after removing the electrode pads, burns were found on the patient's skin.Patient sustained burn marks.This is all the information provided at this time.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections d1 updated, d4 model # updated, d4 catalog # removed, d4 primary udi # updated, d4 expiration date updated.The pro padz were returned to zoll medical pawtucket for evaluation.The pro padz were visually inspected and compared to the assembly drawing with no visual discrepancies noted with the electrode's assembly.Both anterior and posterior electrodes had an excessive amount of hair covering the foam frame.The pads were scrapped after testing.It is important to note that during defibrillation therapy, patients can experience burns and redness due to a high measured patient impedance.The pro-padz liquid gel radiolucent ifu (aw-r1345-64) states: remove excess chest hair.Clip if necessary to maximize gel to skin contact.Excessive hair can inhibit good coupling (contact), which can lead to the possibility of arcing and skin burns.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO PADZ
• Common Device Name: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 19212684
• Report Number: 1218058-2024-00040
• Device Sequence Number: 15480140
• Product Code: MKJ
• UDI-Device Identifier: 00847946016401
• UDI-Public: (01)00847946016401(17)241118(10)4623
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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
• Operator of Device: Other
• Device Expiration Date: 11/18/2024
• Device Model Number: 8900-2106-01
• Device Catalogue Number: 8900-4006
• Device Lot Number: 4623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male