MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION MULTI-FUNCTION RADIOTRANSPARENT DEFIBRILLATOR ELECTRODE; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number MDSZOL200

Patient Problem Skin Discoloration (2074)

Event Date 06/02/2023

Event Type  Injury  

Event Description

Patient was undergoing a cardioversion when the staff heard a loud popping noise and smelled burning.Upon inspection, the patient had three blue marks on their chest under the pads.It is believed that the sternal wires conducted the current causing arcing.Medline.

• Brand Name: MULTI-FUNCTION RADIOTRANSPARENT DEFIBRILLATOR ELECTRODE
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 17371533
• MDR Text Key: 319568861
• Report Number: MW5119770
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDSZOL200
• Device Lot Number: Y030623-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male