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

Model Number	8900-4006
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while defibrillating a 96-year-old, male patient, the anterior defibrillator pad sparked.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The pro padz electrodes were not returned to zoll medical corporation for evaluation.However, the pads used during the event were evaluated by a zoll field technician at the customer's facility.Upon visual inspection it was noted that the anterior pad had clipped chest hair stuck to it, indicating that the patient's skin was not cleaned prior to pad application according to zoll guidelines.It is important to note that during defibrillation therapy, patients can experience burns and redness due to a high measured patient impedance.This could be for a variety of reasons including, but not limited to, skin preparation, electrode application, or poor coupling.Zoll recommends that patients are clipped and cleaned prior to applying electrode pads to assure good coupling of electrode to skin contact.Analysis for reports of this type has not identified an increase in trend.
Additional Manufacturer Narrative
The product was not returned to zoll medical corporation for evaluation.During a scheduled cardioversion, the anterior defibrillator pad sparked, resulting in a minor first-degree burn to the patient.Device logs confirmed a 294j shock was delivered, with impedance fluctuating from 90.4 to 118 ohms, indicating poor coupling.The electrodes used were not returned for evaluation.The device log was reviewed and confirmed normal shock delivery parameters aside from impedance fluctuation.A device history record (dhr) review of the implicated electrode (lot # 1125a, propadz radiolucent solid gel) showed no manufacturing discrepancies.All retained samples passed impedance and defibrillation testing.The device functioned as designed.The r series operator's guide and instruction for use indicate that poor pad adhesion or air pockets under electrodes can result in arcing and skin burns.Analysis of 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: 22022184
• Report Number: 1218058-2025-00074
• Device Sequence Number: 9530720
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: 00847946016661
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2025

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: 03/11/2026
• Device Model Number: 8900-4006
• Device Lot Number: 1125A
• Was Device Available for Evaluation?: No
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/15/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2025
• 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