MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MEDI-TRACE ADULT DEFIBRILLATOR PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Lot Number 314604X

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Pads were placed to dry skin that was free of lotion or oils.Patient developed burns on the anterior where pads were placed, but not exterior of patient body.The equipment was reviewed by biomed, and it was deemed appropriate and working.

• Brand Name: MEDI-TRACE ADULT DEFIBRILLATOR PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 18371065
• MDR Text Key: 331078507
• Report Number: 18371065
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 314604X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Race: Black Or African American