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

Model Number	8900-4006
Medical Device Problem Codes	Sparking (2595); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), there was a spark seen from the electrode pads and after removing the electrode pads, burns of an unknown degree were found on the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.Please reference medwatch report number 1218058-2025-00032 and 1218058-2025-00035 for similar reports from the same customer.
Additional Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.The customer reported increased sparks and patient burns during cardioversion.Burns may result from high patient impedance due to poor skin prep, incorrect electrode use, or improper handling.The propadz instruction for use (ifu) warns that excessive hair, poor adherence, or air under the electrode can cause arcing and burns.Cardioversion may also cause reddening from hyperemia, which can resemble a burn.The customer did not respond, and neither the electrode nor the device was returned.A dhr review for pro-padz (8900-4005) lot 0125 found no abnormalities.No trend associated with similar reports.

• 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: 21515631
• Report Number: 1218058-2025-00034
• Device Sequence Number: 12767538
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)260101(10)0125
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/11/2025

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: 01/01/2026
• Device Model Number: 8900-4006
• Device Lot Number: 0125
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown