MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER

Model Number	620-0221511-01
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a male patient (age unknown), sparks were emitted from the electrode pads.Complainant indicated that the patient sustained first degree burns.
Additional Manufacturer Narrative
The returned pro-padz radiolucent solid gel electrodes lot 1725c were evaluated and found in good condition, with no exposed conductive elements or damaged wiring.Both pads were covered with long strands of hair, indicating skin preparation was a factor as part of application.Electrical testing showed low pad-to-pad impedance; however, the event logs recorded a high patient impedance of 183 ohms at the time of therapy, which can cause sparking during cardioversion.High impedance is commonly associated with skin prep, proper electrode placement, or poor coupling.Based on the returned pads and event data, the high impedance was attributted to skin preparation.The instructions for use (ifu) for the pro-padz radiolucent electrodes (r1345-112 rev.J) defines the importance of proper skin preparation and electrode application and how lack of either one can lead to possible arcing and skin burns.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Common Device Name: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 23671670
• Report Number: 1220908-2025-04513
• Device Sequence Number: 9846696
• Product Code: MKJ
• UDI-Device Identifier: 00847946018757
• UDI-Public: (01)00847946018757
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/10/2025

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: 620-0221511-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: Male