MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

Model Number WCD 4000

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Atrial Fibrillation (1729)

Event Date 04/25/2015

Event Type  Injury  

Event Description

A us distributor contacted zoll to report that a patient experienced an inappropriate defibrillation event.Rapid atrial fibrillation with a rapid ventricular response contributed to the false detection.The patient was reportedly conscious and was unable to press the response buttons in time.Review of the event confirms the response buttons were pressed after the event.The patient remained at home and continued use of the lifevest.

Manufacturer Narrative

There was no death or device malfunction associated with the inappropriate defibrillation.There is no information to suggest that the patient sustained a serious injury.(other): device evaluation summary: device evaluation was accomplished through a review of the patient's downloaded data file.Review of the data does not indicate any device malfunction related to the defibrillation event.Monitor (b)(4) and electrode belt (b)(4): 12/2014.Additional inappropriate defibrillation narrative: 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.The current commercial inappropriate defibrillation rate is consistent with the observed rate during (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
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 000
• Manufacturer Contact: katelynn mains ; 121 gamma dr; pittsburgh, PA 15238-0000 ; 4129683333
• MDR Report Key: 4774956
• MDR Text Key: 16882232
• Report Number: 3008642652-2015-02870
• 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: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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): Other
• Patient Age: 76 YR