MAUDE Adverse Event Report: CARDINAL HEALTH MEDI-TRACE CADENCE ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 225500A

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685)

Event Date 01/04/2024

Event Type  Injury  

Event Description

Patient underwent scheduled cardioversion.Patient was prepped by shaving chest hair, but back did not need to be shaved as no hair was noted.Aed pads placed on chest and back for procedure.Patient was cardioverted x2 @ 200 jules each time.After procedure, pads were removed and the pad on the back left a red burn mark on the patient's skin that was intact and unbroken.

• Brand Name: MEDI-TRACE CADENCE ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRODES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 18486232
• MDR Text Key: 332793933
• Report Number: MW5150072
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 01/04/2024

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 Catalogue Number: 225500A
• Device Lot Number: 327914X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White