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

Model Number WCD 4000

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Syncope (1610); No Code Available (3191)

Event Date 03/26/2015

Event Type  Injury  

Event Description

A us distributor contacted zoll to report that a patient experienced a defibrillation event.The patient reportedly had a syncopal episode at the time of the event.A 150 joule pulse was delivered at 20:47:32 on (b)(6) 2015.The ecg at the time of the shock is not available for review.The response buttons were not pressed during the entire event.The patient went to the hospital following the event and ended use of the lifevest in order to receive and icd.

Manufacturer Narrative

There was no death associated with the defibrillation.Device evaluation of electrode belt sn (b)(4)was accomplished through a review of the patient's downloaded data file.Review of the data does not indicate any belt malfunction related to the defibrillation event.Device evaluation of monitor sn (b)(4) was completed.The reported problem (ecg not available) was confirmed.As received, the monitor was unable to mount the sd card at device start-up.This failure did not affect the device's ability to detect an arrhythmia and deliver a treatment defibrillation.The monitor passed all functional testing upon receipt.Device manufacture date: monitor sn (b)(4)- (reuse); electrode belt sn (b)(4)- 11/2013 (reuse).Inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.(b)(4).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 http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: jeremy silver ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4746101
• MDR Text Key: 5709012
• Report Number: 3008642652-2015-02761
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• 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?: Yes
• Date Returned to Manufacturer: 03/31/2015
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR