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

Model Number T100AC-PHYSIO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

Review of documentation shows that the device met all performance requirements as intended when the device was released and shipped.Sample returned also show no indications that the pads did not meet performance specification.

Event Description

Cardioversion pads were placed to the anterior and posterior chest of a patient.After the 2nd set of 200j cardioversion, the anterior pad caught fire.The patient sustained burns to the chest.

• Brand Name: HEARTSYNC BY NISSHA MEDICAL
• Type of Device: 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: 18869320
• MDR Text Key: 337258036
• Report Number: 1317188-2024-00002
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00009336009541
• UDI-Public: 00009336009541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Device Model Number: T100AC-PHYSIO
• Device Catalogue Number: 6600093H
• Device Lot Number: Y080823-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other