MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART PAD ADULT/CHILD PLUS MULTIFUNCTION ELECTRODE PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number M3713A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 03/01/2020

Event Type  malfunction  

Event Description

Patient sustained small area of superficial soft tissue burn during synchronized cardioversion.Phillips pads on anterior chest application have two burn spots on top of pads that correlates to patient burn area.Pads seemed to be secured appropriately in front to back formation.No obvious injury related to posterior pad.

• Brand Name: HEARTSTART PAD ADULT/CHILD PLUS MULTIFUNCTION ELECTRODE PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 9859632
• MDR Text Key: 184266499
• Report Number: 9859632
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3713A
• Device Catalogue Number: M3713A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other