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

Model Number	8900-4006
Medical Device Problem Codes	Sparking (2595); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while defibrillating a male patient (age unknown), the electrode pads sparked burning the patient.The patient's skin is red but not blistered.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The pro-padz were returned to zoll medical corporation for evaluation.The issue could not be duplicated using a test unit.Visual inspection of the returned electrodes revealed no signs of burns or damaged, though minor gel rippling was observed on the front pad.Continuity testing passed without issue.No evidence of poor electrode-to-skin coupling was found, which is typically the cause of arcing if air pockets are present.Reddening of the skin can occur normally following high- energy cardioversion.After testing, the pads were scrapped.No trend is associated with reports of this type.

• 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: 22341251
• Report Number: 1218058-2025-00100
• Device Sequence Number: 8930563
• Product Code: MKJ
• UDI-Device Identifier: 00847946016463
• UDI-Public: (01)00847946016463(17)260115(10)0325B
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• 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): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/15/2026
• Device Model Number: 8900-4006
• Device Lot Number: 0325B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Patient Sex: Male