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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS HEARTSTART PAD ADULT/CHILD PLUS MULTIFUNCTION ELECTRODE PADS AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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.
 
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Brand NameHEARTSTART PAD ADULT/CHILD PLUS MULTIFUNCTION ELECTRODE PADS
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd
andover MA 01810
MDR Report Key9859632
MDR Text Key184266499
Report Number9859632
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
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
Date FDA Received03/20/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3713A
Device Catalogue NumberM3713A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/05/2020
Event Location Hospital
Date Report to Manufacturer03/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/20/2020 Patient Sequence Number: 1
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