MAUDE Adverse Event Report: CARDIO MEDICAL PRODUCTS, INC. CARDIO CLEAR; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number	Z100
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During cardioversion procedure, when physician pressed button to defib patient, the defib cardio clear pad ignited in flames which caught surrounding bedding and oxygen mask to also ignite.Fda safety report id# (b)(4).

• Brand Name: CARDIO CLEAR
• Common Device Name: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): CARDIO MEDICAL PRODUCTS, INC.
• MDR Report Key: 15551194
• Report Number: MW5112463
• Device Sequence Number: 2780637
• Product Code: LDD
• UDI-Device Identifier: 00814907020265
• UDI-Public: (01)00814907020265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/05/2022

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 Expiration Date: 04/28/2025
• Device Model Number: Z100
• Device Catalogue Number: Z100
• Device Lot Number: Y042822-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White