LIFEVEST WCD 4000 SYSTEM

Report

Report Number: 3008642652-2015-03332
Event Type: Injury
Date Received: May 20, 2015
Date of Event: April 18, 2015
Report Date: May 15, 2015
Manufacturer: ZOLL MANUFACTURING CORPORATION
Product Code: MVK
PMA / PMN Number: P010030
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION. 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) - REUSE. ELECTRODE BELT: (B)(4): 01/01/2014 - REUSE. INAPPROPRIATE DEFIBRILLATIONS ARE ON 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.

Description of Event or Problem · 1

A US DISTRIBUTOR CONTACTED ZOLL ON (B)(6) 2015 TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT WHILE AT HOME. THE PATIENT WAS TREATED AT 06:40:42 ON (B)(6) 2015. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. A REVIEW OF THE EVENT INDICATES THAT THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE PATIENT WENT TO THE HOSPITAL FOLLOWING THE TREATMENT AND CONTINUED USE OF THE LIFEVEST.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
327347	LIFEVEST WCD 4000 SYSTEM	WEARABLE CARDIOVERTER DEFIBRILLATOR	MVK	ZOLL MANUFACTURING CORPORATION	WCD 4000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Hospitalization\| O