MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ; ELECTRODES

Model Number	8900-4006
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to cardiovert a 64-year-old male patient, the device sparked.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was not returned to zoll medical corporation for evaluation.The customer provided logs and pictures for review.On (b)(6) 2025, a 64-year-old male patient underwent cardioversion using a zoll r series defibrillator and propadz radiolucent electrodes.The first shock (200j) was delivered with a patient impedance of 91.8 ohms; the second shock (also 200j) showed an increased patient impedance of 103.9 ohms and defibrillator impedance discrepancy of 40 ohms.The anterior electrode pad reportedly arced or lit up during the event.Upon inspection, residual clipped chest hair was found adhered to the pad, indicating inadequate skin preparation.No device malfunction was identified.Per the r series operator's guide (9650-0912-01 rev.Ya), inadequate pad adhesion and/or air pockets under the electrodes can result in arcing and potential skin burns.Additionally, the instructions for use for pro-padz radiolucent (r1345-112 rev.J) recommend ensuring the skin is clean and dry under the electrode.Remove any debris, ointments, skin preps, etc., with water (and mild soap if needed).Wipe off excess moisture/diaphoresis with a dry cloth.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: PRO PADZ
• Common Device Name: ELECTRODES
• 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: 22786801
• Report Number: 1218058-2025-00134
• Device Sequence Number: 8236756
• Product Code: MKJ
• UDI-Device Identifier: 00847946016463
• UDI-Public: (01)00847946016463(17)270319(10)1225C
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: Health Professional
• Device Model Number: 8900-4006
• Device Lot Number: 1225C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2025
• 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 Age: 64 YR
• Patient Sex: Male