MAUDE Adverse Event Report: GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES ZOLL; DEFIBRILLATOR PAD

Model Number	8900-004041-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the batch record for the lot was completed.There was no noted non-conformances in process and with the raw material.The retain sample was used for testing, the arc/spark could not be recreated with the retain.No further action is required.
Event or Problem Description
During code of a patient, pads became noticeably warm.During the 3rd shock there was a spark from the pad and the smell of smoke.Patient sustained a burn.

• Brand Name: ZOLL
• Common Device Name: DEFIBRILLATOR PAD
• Manufacturer (Section D): GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: juliana scotto di carlo ; 400 exchange street; buffalo, NY 14204 ; 7168496419
• MDR Report Key: 21929564
• Report Number: 1317188-2025-00004
• Device Sequence Number: 13033161
• Product Code: MKJ
• UDI-Device Identifier: 30009336010326
• UDI-Public: 30009336010326
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P200007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: Health Professional
• Device Model Number: 8900-004041-01
• Device Catalogue Number: 700001832
• Device Lot Number: Y121323-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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