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

Model Number WCD 4000

Device Problems Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Death (1802)

Event Date 11/20/2017

Event Type  Death  

Manufacturer Narrative

Device evaluation summary: device evaluation of monitor sn (b)(4) and belt sn (b)(4) has been completed.As received, the monitor and belt passed incoming functional testing.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, audio messaging, and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.Device manufacture date: monitor: 06/18/2012; belt: 03/23/2015.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2017 at 2am while wearing the lifevest.The patient's daughter reported that the device did not shock the patient but alarmed to perform cpr.The patient's daughter attempted cpr but the patient was unable to be revived.Review of the download data indicates that the patient first detected bradycardia from 11:48:39 to 11:51:41 pm on (b)(6) 2017.At 11:53:53 the device detected an arrhythmia.The ecg recordings showed that the patient was in an idioventricular rhythm at 70 bpm.The device exited the treatment sequence at 11:54:15 and detected asystole at 11:54:36 pm.At 11:54:44 and 11:55:42, the device flags indicated that a treatable rhythm was detected before the device was shutdown at 11:55:43 pm.The continuous ecg data showed that the patient was in vf with varying amplitude at these times, until the device was shutdown.The patient was not treated due to the varying amplitude and subsequent device deactivation.The device was powered back on at 12:03:16 am on (b)(6) 2017 and asystole was detected at 12:04:41.Asystole is considered a non-shockable rhythm.The patient was in asystole at the time of device shutdown at 12:04:55am on (b)(6) 2017.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: allison petzold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7247618
• MDR Text Key: 99215031
• Report Number: 3008642652-2018-01262
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• 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: Other
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2012
• 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): Death
• Patient Age: 70 YR