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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Idioventricular Rhythm (1923); Tachycardia (2095); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 12/01/2021

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021.Review of the patient's download data indicates the patient received thirteen appropriate shocks and one inappropriate shock that induced vt in response to oversensing of low amplitude cardiac signal on the date of passing.The device was started up at 23:29:07 on (b)(6) 2021.The patient was in sinus rhythm at 90 bpm at 05:16:53.The patient's rhythm then transitioned to vt at 260 bpm.The patient received the first appropriate shock at 05:17:29.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was vt at 260 bpm.The patient received the second appropriate shock at 05:17:56.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was sinus bradycardia at 30 bpm with nsvt.The patient received the third appropriate shock at 05:18:22.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was a sinus beat which transitioned to vt at 260 bpm.The patient received the fourth appropriate shock at 05:18:49.The patient's rhythm at the time of the shock was vt at 260 bpm.The patient's post-shock rhythm was sinus bradycardia at 40 bpm which transitioned to vt at 270 bpm.The patient received the fifth appropriate shock at 05:19:16.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was sinus bradycardia at 15 bpm.The patient was in an idioventricular rhythm at 80 bpm at 05:35:37.The patient's rhythm then degraded to vf with motion artifact.The patient received the sixth appropriate shock at 05:36:07.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was asystole for 10 seconds, transitioning to severe bradycardia at 10 bpm.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient was in an idioventricular rhythm at 40 bpm with nsvt at 05:40:34.The patient's rhythm then degraded to vf with motion artifact.The patient received the seventh appropriate shock at 05:41:04.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was an idioventricular rhythm at 30 bpm, degrading to vf with motion artifact.The patient received the eighth appropriate shock at 05:41:31.The patient's rhythm at the time of the shock and post-shock rhythm were vf with motion artifact.The patient received the ninth appropriate shock at 05:41:58.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was a pause, transitioning to vf with motion artifact.The patient received the tenth appropriate shock at 05:42:25.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was asystole for 7 seconds, transitioning to vf with motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the eleventh appropriate shock at 05:42:52.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was asystole for 5 seconds, transitioning to vf with motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the twelfth appropriate shock at 05:46:37.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was asystole.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the thirteenth appropriate shock at 05:50:57.The patient's rhythm at the time of the shock was vf with cpr/motion artifact.The patient's post-shock rhythm was asystole.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the inappropriate shock at 05:51:26.The patient's rhythm at the time of the shock was asystole.The patient's post-shock rhythm was induced vt at 180 bpm.The patient was in vt at 170 bpm at 05:52:34.The patient's rhythm then degraded to asystole.The lifevest detected the vt arrhythmia, but the rhythm degrading to asystole prevented delivery of a shock.The patient was last seen in asystole with intermittent cardiac activity at 11:27:29.

Manufacturer Narrative

The monitor and electrode belt have not been recovered.The device flag data from the last download ((b)(6) 2021) 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.No deficiencies alleged.Device manufacture date: monitor 08/27/2019, belt 07/23/2015.

Manufacturer Narrative

The monitor and electrode belt have not been recovered.The device flag data from the last download ((b)(6) 2021) 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.No deficiencies alleged.H.4.Device manufacture date; monitor 08/27/2019, belt 07/23/2015.

Event Description

Per continuous ecg recording, the patient received 1 additional inappropriate treatment from the lifevest.At 11:43:22, the patient received an inappropriate treatment.The patient's rhythm at the time of the treatment event was asystole with motion artifact.The patient's post-shock rhythm was asystole with motion artifact and intermittent cardiac activity.Oversensing of cardiac signal contributed to the false detection.A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021.Review of the patient's download data indicates the patient received thirteen appropriate shocks and one inappropriate shock that induced vt in response to oversensing of low amplitude cardiac signal on the date of passing.The device was started up at 23:29:07 on (b)(6) 2021.The patient was in sinus rhythm at 90 bpm at 05:16:53.The patient's rhythm then transitioned to vt at 260 bpm.The patient received the first appropriate shock at 05:17:29.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was vt at 260 bpm.The patient received the second appropriate shock at 05:17:56.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was sinus bradycardia at 30 bpm with nsvt.The patient received the third appropriate shock at 05:18:22.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was a sinus beat which transitioned to vt at 260 bpm.The patient received the fourth appropriate shock at 05:18:49.The patient's rhythm at the time of the shock was vt at 260 bpm.The patient's post-shock rhythm was sinus bradycardia at 40 bpm which transitioned to vt at 270 bpm.The patient received the fifth appropriate shock at 05:19:16.The patient's rhythm at the time of the shock was vt at 250 bpm.The patient's post-shock rhythm was sinus bradycardia at 15 bpm.The patient was in an idioventricular rhythm at 80 bpm at 05:35:37.The patient's rhythm then degraded to vf with motion artifact.The patient received the sixth appropriate shock at 05:36:07.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was asystole for 10 seconds, transitioning to severe bradycardia at 10 bpm.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient was in an idioventricular rhythm at 40 bpm with nsvt at 05:40:34.The patient's rhythm then degraded to vf with motion artifact.The patient received the seventh appropriate shock at 05:41:04.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was an idioventricular rhythm at 30 bpm, degrading to vf with motion artifact.The patient received the eighth appropriate shock at 05:41:31.The patient's rhythm at the time of the shock and post-shock rhythm were vf with motion artifact.The patient received the ninth appropriate shock at 05:41:58.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was a pause, transitioning to vf with motion artifact.The patient received the tenth appropriate shock at 05:42:25.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was asystole for 7 seconds, transitioning to vf with motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the eleventh appropriate shock at 05:42:52.The patient's rhythm at the time of the shock was vf with motion artifact.The patient's post-shock rhythm was asystole for 5 seconds, transitioning to vf with motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the twelfth appropriate shock at 05:46:37.The patient's rhythm at the time of the shock was vf.The patient's post-shock rhythm was asystole.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the thirteenth appropriate shock at 05:50:57.The patient's rhythm at the time of the shock was vf with cpr/motion artifact.The patient's post-shock rhythm was asystole.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient received the inappropriate shock at 05:51:26.The patient's rhythm at the time of the shock was asystole.The patient's post-shock rhythm was induced vt at 180 bpm.The patient was in vt at 170 bpm at 05:52:34.The patient's rhythm then degraded to asystole.The lifevest detected the vt arrhythmia, but the rhythm degrading to asystole prevented delivery of a shock.The patient was last seen in asystole with intermittent cardiac activity at 11:27:29.

• 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13196792
• MDR Text Key: 283470823
• Report Number: 3008642652-2022-00370
• 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,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• 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