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

Model Number	8900-4006
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleged that while defibrillating a 87-year-old male patient, sparks were emitted from the electrode pads leaving burns on the patient.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
The electrodes were returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.During inspection of the electrodes, no defects were found.Normal discoloration indicated energy discharge; the device history is normal; high impedance can result from improper application; ifu emphasizes proper skin preparation and avoiding air pockets to prevent arcing and burns.The pads were scrapped after testing.No trend is associated with reports of this type.

• 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: 23645744
• Report Number: 1218058-2025-00186
• Device Sequence Number: 10108422
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)260923(10)3925
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/06/2025

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: 09/23/2026
• Device Model Number: 8900-4006
• Device Lot Number: 3925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male