MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	8900-4006
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2026
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 did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Event or Problem Description
Complainant alleged that while attempting to treat a 69-year-old male patient, a spark was emitted from the pads.
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 a2, a3a, b3, b5, and d2.The customer reported sparking during defibrillation therapy.The pads were discarded by the customer and were not returned for evaluation; therefore, retained samples testing could not be performed.Review of the provided photograph showed skin reddening in an area with significant body hair.Skin burns, including first degree burns, are a known potential risk associated with defibrillation therapy, particularly when adequate skin preparation is not performed in accordance with the ifu.Poor electrode adhesion and/or air trapped beneath the electrodes may increase the likelihood of arching and contribute to skin burns.Based on the available information, the likely contributing factor was inadequate patient skin preparation, which may have allowed air pockets beneath the electrode and contributed to arching.No information was provided confirming that a burn or a serious injury occurred.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: PRO-PADZ
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 24897493
• Report Number: 1218058-2026-00053
• Device Sequence Number: 21034133
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)270128(10)0526A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/26/2026

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: 0526A
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2026
• 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 Age: 69 YR
• Patient Sex: Male