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

Model Number	8900-4006
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/06/2025
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 male patient (age unknown), the electrode pads sparked burning the patient.The patient's skin is red but not blistered.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the electrode pads, on report 1218058-2025-00100, and the customer's report was not replicated or confirmed.The electrodes passed all functional testing with no signs of damage or malfunction.There was no evidence of sparking, which would typically appear as a darkened area or burn mark.The pads show no signs of arcing, and patient skin reddening is not unexpected during cardioversion.It's important to note that reddening of the skin can be a normal physiological response to high-energy cardioversion, especially in patients with good blood circulation.No indicators of poor coupling or sparking were observed in this case.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: 22319454
• Report Number: 1218058-2025-00101
• Device Sequence Number: 21035749
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(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?: 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: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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