MAUDE Adverse Event Report: CARDINAL HEALTH DEFIBRILLATION PADS - ADULT; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Lot Number 313079X

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/28/2023

Event Type  Injury  

Event Description

During a direct current cardioversion to treat his atrial flutter there was a spark on the anterior left chest pad.Patient converted to sinus rhythm after 1 shock at 250 joules and pad was removed from patient's chest.Two thermal burns approximately 1/2"x2" were found.Reference report: mw5145158.

• Brand Name: DEFIBRILLATION PADS - ADULT
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 17689817
• MDR Text Key: 322941534
• Report Number: MW5145159
• Device Sequence Number: 1
• Product Code: DRO
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 313079X
• 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
• Treatment: LIFEPAK 20E.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White