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

Model Number	8900-4006
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/17/2026
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 attempting to defibrillate a patient (age & gender unknown), after discharge a popping noise was heard and the pads were removed and noted a burn on the patient's left torso.The degree of burn was not provided.
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 section b1, b2, d2, h1, and h6 (health effect clinical and impact code).The returned pads were received in a compromised condition with the package opened and the gel surfaces adhered together; however, visual inspection found no evidence of arcing or burn marks.Impedance/continuity testing and a 200 j shock test were performed with passing results, and no discrepancies were identified.Review of the clinical file confirmed that on (b)(6) 2026, the device delivered a 200 j synchronized shock with an actual delivered energy of 271.10 j and a recorded patient impedance of 263 ohms.Ecg artifact was also observed.Defibrillation impedance could not be fully assessed because the requested activity log was not provided.Based on the available evidence, the reported condition may have been associated with poor pad-to-patient coupling or intermittent accessory cable connection.Factors such as inadequate skin preparation, electrode application, or patient movement may contribute to poor coupling.The evaluation did not identify a malfunction with the returned pads.Per the onestep basic's instruction for use (ifu): remove excess chest hair.Clip if necessary to maximize gel to skin contact.Clipping is recommended since shaving can leave tiny micro-abrasions that can lead to patient discomfort during pacing.Ensure skin is clean and dry under electrode.Remove any debris, ointments, skin preps, etc.With water (and mild soap if needed).Wipe off excess moisture/diaphoresis with dry cloth.Apply one edge of the electrode securely to the patient.Roll the electrode smoothly from that edge to the other.Be careful not to trap any pockets of air between the gel and skin.Excessive hair can inhibit good coupling (contact), which can lead to the possibility of arcing and skin burns.Analysis of 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 ; +1(401)729-1400
• MDR Report Key: 24551383
• Report Number: 1218058-2026-00034
• Device Sequence Number: 18459608
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)261025(10)4325B
• 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
• Report Source: Foreign,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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 Model Number: 8900-4006
• Device Lot Number: 4325B
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2025
• 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