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

Model Number	8900-004041-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer was unable to shock a patient out of a-fib after 4 attempts.User swapped out the pads and was able to successfully convert after one shock.
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 reported malfunction could not be recreated with the retain.No further action is required.

• 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: amy intini ; 400 exchange street; buffalo, NY 14204 ; 7165078135
• MDR Report Key: 24569494
• Report Number: 1317188-2026-00039
• Device Sequence Number: 8366761
• Product Code: MKJ
• UDI-Device Identifier: 30009336010326
• UDI-Public: 30009336010326
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: Health Professional
• Device Model Number: 8900-004041-01
• Device Catalogue Number: 700001832
• Device Lot Number: Y061025-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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 Sex: Unknown