MAUDE Adverse Event Report: ZOLL LIFE VEST; AUTOMATIC EXTERNAL DEFIB

Device Problem Leak/Splash (1354)

Patient Problems Scarring (2061); Caustic/Chemical Burns (2549)

Event Date 10/02/2015

Event Type  Injury  

Event Description

This happened to my (b)(6) daughter.She was put on a zoll life vest to be able to go home from the hospital.She wore it for a month.Then on (b)(6) 2015, she screamed and i ran in to see that the gel was busted out of the pad and had chemically burned her.The gel busted out was heated by the pad and burned my child.This happened when the monitor never went off once.The monitor was never used.This happened a total of 6 times within one and one half months, until a new surgeon told me to get it off her.Left a burn scar and scared my child, so that she has nightmares still and her emotional attitude has changed for the worst.

• Brand Name: LIFE VEST
• Type of Device: AUTOMATIC EXTERNAL DEFIB
• Manufacturer (Section D): ZOLL
• MDR Report Key: 7273157
• MDR Text Key: 100306517
• Report Number: MW5075258
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 48