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

Model Number	C100AC-PHYSIO
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was completed for the lot in question.There were no noted non-conformances during production or associated with the raw material lots used.There have been no other complaints for this lot.Testing of the retain is underway to determine if the complaint can be replicated.
Event or Problem Description
End user states that the defib pad seems to not communicate with the lifepak and loses connection at times.It was stated that only this lot has been an issue.
Additional Manufacturer Narrative
Devices from the end user were returned for testing.The samples from the customer and the retains from the production lot were tested.There was no loss of connection observed and all shocks were delivered as anticipated.The malfunction cannot be replicated and complaint cannot 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: 21066322
• Report Number: 1317188-2025-00001
• Device Sequence Number: 19653062
• Product Code: MKJ
• UDI-Device Identifier: 50009336009485
• UDI-Public: 50009336009485
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: Y092524-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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
• Patient Sex: Unknown