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

Model Number Z100

Device Problem Fire (1245)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2022

Event Type  Injury  

Event 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
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): CARDIO MEDICAL PRODUCTS, INC.
• MDR Report Key: 15551194
• MDR Text Key: 301263548
• Report Number: MW5112463
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00814907020265
• UDI-Public: (01)00814907020265
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White