MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL ELECTRODE PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number PRO-PADS REF 8900-4006

Device Problems Device Emits Odor (1425); Sparking (2595); Excessive Heating (4030)

Patient Problem Burn, Thermal (2530)

Event Date 01/22/2021

Event Type  Injury  

Event Description

Pt hooked up to zoll monitor; protocol followed for cardioversion.Shocked x1 at 200 joules.With the deliverance of this shock, a spark was seen and a loud "pop" was heard, followed by a burning smell.The patient was immediately checked for complications and a burn was noticed underneath the anterior defibrillator pad on his chest.Fda safety report id#: (b)(4).

• Brand Name: ZOLL ELECTRODE PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 11243432
• MDR Text Key: 229646000
• Report Number: MW5099050
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 01/25/2021

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 Model Number: PRO-PADS REF 8900-4006
• Device Catalogue Number: NOT AVAILABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 143