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

Model Number	8900-4006
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
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 attempting to treat a patient (age & gender unknown), a spark was emitted from the pads.Complainant indicated that the patient sustained minor skin burns.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections 3a and b5.Two sets of pro-padz electrodes lot# 0426 were returned for evaluation.One set was received without packaging and the padz were adhered inside a plastic bag, while the second set was returned in opened packaging with the pads stuck together face to face.Evaluation of the first set identified remnants of unshaven hair, which may indicate poor coupling between the electrodes and the patient's skin.Poor coupling may contribute to sparking or arching during therapy delivery.No odor, burns, or other anomalies were observed.Proper skin preparation in accordance with the ifu, reduces poor coupling.Evaluation and continuity testing of both sets of electrodes revealed no functional discrepancies, and both passed continuity testing from the connector to the tins.The electrodes were scrapped following evaluation.Analysis of reports of this type has not identified an increase in trend.
Event or Problem Description
Complainant alleged that while attempting to treat a male patient (age unknown), a spark was emitted from the pads.Complainant indicated that the patient sustained minor skin burns.

• 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: 24746833
• Report Number: 1218058-2026-00046
• Device Sequence Number: 15782571
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)280124(10)0426
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/11/2026

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 Model Number: 8900-4006
• Device Lot Number: 0426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2026
• 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