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

Model Number	C100AC-PHYSIO
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Nurse heard a buzzing sound and saw a flash at pad during cardioversion.Flash was at edge of blue wire and a black mark was left at location.Patient was not harmed.
Additional Manufacturer Narrative
A review of the dhr was completed and there were no noted non-conformances with the raw material lots used and no in-process failures.The returned sample was tested by sending shocks through the pad to try and simulate the event described.However, the event could not be recreated.No further corrections are warranted at this time given the review of both the dhr and sample returned.The complaint could not be confirmed.

• Brand Name: HEARTSYNC BY NISSHA MEDICAL
• 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: 21354201
• Report Number: 1317188-2025-00002
• Device Sequence Number: 9003780
• Product Code: MKJ
• UDI-Device Identifier: 00009336009480
• UDI-Public: 00009336009480
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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: Health Professional
• Device Model Number: C100AC-PHYSIO
• Device Catalogue Number: 6600017H
• Device Lot Number: Y111124-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (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
• Patient Sex: Unknown