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	04/19/2026
Type of Reportable Event	Malfunction
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 defibrillating a patient (age & gender unknown), an arc was heard from the electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• 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 ; +1(401)729-1400
• MDR Report Key: 25111416
• Report Number: 1218058-2026-00059
• Device Sequence Number: 16037020
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)270404(10)1426A
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 1426A
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown