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

Model Number WCD 4000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 05/12/2018

Event Type  Death  

Manufacturer Narrative

Monitor sn (b)(4) and electrode belt sn (b)(4) have not yet been recovered from the field.The last download occurred on (b)(6) 2018, prior to the patient death.There is no download data available surrounding the death.The device flag data from the last download ((b)(6) 2018) does not indicate any device malfunction.The review of the data indicated that the device powered on normally and was able to acquire the patient's ecg signal on the last day of use captured in the data download.At this time, there is no indication of a device malfunction.

Event Description

A us distributor reported that a patient passed away on (b)(6) 2018 while reportedly wearing the lifevest.The patient's wife alleged that the lifevest was not working during the time.The patient's wife also reported that the device was cut off the patient.No further details surrounding the event are known.The monitor and electrode belt have not yet been recovered from the field.The last download occurred on (b)(6) 2018, prior to the patient death.There is no download data available surrounding the death.The device flag data from the last download ((b)(6) 2018) does not indicate any device malfunction.The review of the data indicated that the device powered on normally and was able to acquire the patient's ecg signal on the last day of use captured in the data download.Submitting mdr out of an abundance of caution due to the wife's allegation that the lifevest was not working.A supplemental report will be sent upon receipt of the equipment.

Manufacturer Narrative

Initial report: monitor sn (b)(4) and electrode belt sn (b)(4 have not yet been recovered from the field.The last download occurred on (b)(6) 2018, prior to the patient death.There is no download data available surrounding the death.The device flag data from the last download (b)(6) 2018) does not indicate any device malfunction.The review of the data indicated that the device powered on normally and was able to acquire the patient's ecg signal on the last day of use captured in the data download.At this time, there is no indication of a device malfunction.Supplemental report: device evaluation of monitor sn 07077338 and electrode belt sn 59107314 has been completed.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 dates: monitor: 06/13/2014, electrode belt: 01/21/2015.

Event Description

Initial report: a us distributor reported that a patient passed away on (b)(6) 2018 while reportedly wearing the lifevest.The patient's wife alleged that the lifevest was not working during the time.The patient's wife also reported that the device was cut off the patient.No further details surrounding the event are known.The monitor and electrode belt have not yet been recovered from the field.The last download occurred on (b)(6) 2018, prior to the patient death.There is no download data available surrounding the death.The device flag data from the last download (b)(6) 2018) does not indicate any device malfunction.The review of the data indicated that the device powered on normally and was able to acquire the patient's ecg signal on the last day of use captured in the data download.Submitting mdr out of an abundance of caution due to the wife's allegation that the lifevest was not working.A supplemental report will be sent upon receipt of the equipment.Supplemental report: per clinical review of the available download data, bradycardia status flags were detected at 12:46:13 am on (b)(6) 2018.At 12:47:44 am, asystole was detected with the ecg showing sinus bradycardia at 25 bpm slowing to asystole.Asystole was then detected at 12:50:24 am with the ecg showing an idioventricular rhythm at 50 bpm slowing to asystole.The response buttons were pressed at 12:52:14 am.It is unknown who pressed the response buttons.At 01:10:54 am, asystole was detected with the ecgs showing probable cpr then asystole.At 01:13:21, an arrhythmia was detected with the ecgs showing probable cpr then asystole.At 01:13:38 am asystole was detected with the ecgs showing probably cpr then asystole.The electrode belt was disconnected at 01:17:35 am.Subsequent monitoring of the patient was not possible due to the electrode belt disconnection.There is no indication that the lifevest caused or contributed to the patient's death.Asystole and bradycardia are considered non-shockable rhythms.While monitoring the patient, no vt/vf was detected.

• 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
• MDR Report Key: 7649854
• MDR Text Key: 112705903
• Report Number: 3008642652-2018-05820
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• 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,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 11/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 43 YR