MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Defibrillation/Stimulation Problem (1573)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 12/30/2014

Event Type  Injury  

Event Description

A zoll distributor contacted zoll to report that a pt experienced an inappropriate defibrillation event.The pt was treated at 06:52:12 on (b)(6) 2014.Motion artifact contributed to the false detection.The pt was conscious at the time of the event.The response buttons were not pressed prior to the treatment.The pt did not seek medical attention and continued to use the lifevest.

Manufacturer Narrative

There was no death or device malfunction associated with the inappropriate defibrillation.There is no info to suggest that the pt sustained a serious injury.(other): device eval was accomplished through a review of the pt's downloaded data file.Review of the data does not indicate any device malfunction related to the defibrillation event.Device mfr date: monitor # (b)(4): (b)(4) 2014 - initial use; electrode belt # (b)(4): (b)(4) 2013 - reuse.Inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Pts are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.The current commercial inappropriate defibrillation rate is consistent with the observed rate during the (b)(6) trial.A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at (b)(6).

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: zachary nelson ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4456969
• MDR Text Key: 5397901
• Report Number: 3008642652-2015-00161
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR