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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Defibrillation/Stimulation Problem (1573)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 03/22/2020

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) has been completed.The reported problem (patient death) was confirmed.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.There is no indication of a product malfunction.Manufacture dates: monitor sn (b)(4) - 08/15/2014, electrode belt sn (b)(4) - 08/07/2014.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020 at approximately 5:00 pm.It was reported that the patient was in a nursing home at the time of passing, where emergency medical personnel attempted resuscitation.Per clinical review of the patient's ecg recordings, the patient was in asystole with pacemaker spikes and cpr/motion artifact.The rhythm then transitioned to ventricular tachyardia (vt) at 120 bpm with pacemaker spikes and cpr/motion artifact.The rhythm then degraded to ventricular fibrillation (vf) with cpr/motion artifact.The patient received a non-lifevest defibrillation.The patient's rhythm at time of non-lifevest treatment was vf with pacemaker spikes and cpr/motion artifact and the patient's post shock rhythm was asystole with pacemaker spikes and cpr/motion artifact.The patient was in vf for 2 minutes and 33 seconds before receiving the non-lifevest treatment.The cpr/motion artifact prevented the lifevest from delivering a treatment.The patient was then seen in asystole with intermittent cardiac activity and cpr/motion artifact.The patient's rhythm then transitioned to an idioventricular rhythm at 80 bpm with pacemaker spikes and cpr/motion artifact.The rhythm then degraded to vt at 120 bpm with pacemaker spikes and cpr/motion artifact.The rhythm then degraded even further to vf with cpr/motion artifact.The patient then received a 2nd non-lifevest defibrillation.The patient's rhythm at time of non-lifevest treatment was vf with cpr/motion artifact and the patient's post shock rhythm was asystole with pacemaker spikes and cpr/motion artifact.The patient was in vf for 3 minutes and 4 seconds before receiving the non-lifevest treatment.The cpr/motion artifact prevented the lifevest from delivering a treatment.The rhythm then transitioned to an idioventricular rhythm at 50 bpm.The rhythm then degraded to vt at 120 bpm with pacemaker spikes and cpr/motion artifact.The rhythm then degraded to vf with cpr/motion artifact.The rhythm then transitioned to vt at 100 bpm with cpr/motion artifact.The patient then received a 3rd non-lifevest defibrillation.The patient's rhythm at time of treatment was an idioventricular rhythm at 70 bpm and the patient's post shock rhythm was asystole with pacemaker spikes and cpr/motion artifact.The patient was in vf for approximately 27 seconds before receiving the non-lifevest treatment.The cpr/motion artifact prevented the lifevest from delivering a treatment.The rhythm then transitioned to an idioventricular rhythm from 40 bpm to 70 bpm with pacemaker spikes.The rhythm then degraded to vt at 100 bpm.Lastly, the patient was in an idioventricular rhythm at 60 bpm transitioning to vt at 140 bpm from approx.17:07:06 until the electrode belt disconnection at 17:52:52 on (b)(6) 2020.The patient subsequently passed away.There is no indication that a device malfunction caused or contributed to the patient's death.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: eliza schally ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10026394
• MDR Text Key: 189924591
• Report Number: 3008642652-2020-03890
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2014
• 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): Death
• Patient Age: 81 YR