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

Model Number WCD 4000

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problems Bradycardia (1751); Tachycardia (2095); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)

Event Date 01/15/2022

Event Type  Death  

Manufacturer Narrative

During servicing of a monitor, which was returned for investigation into a patient death, a reportable malfunction was found.The monitor failed incoming functional testing.Upon investigation the monitor failed incoming functional testing.The cause for the failure was isolated to an open (b)(4) driven ground resistor on the computer/analog board.The root cause for the open resistor could not be positively identified.The open (b)(4) resistor is consistent with the patient receiving an external defibrillation while wearing the lifevest.There is no indication that the monitor malfunction contributed to the patient passing as the patient as in a non-treatable rhythm at the time the electrode belt was disconnected.The electrode belt has not been recovered.The device flag data from the last download does not indicate any device malfunction.

Event Description

During servicing of an electrode belt, which was returned for investigation into a patient death, a reportable malfunction was found.The monitor failed incoming functional testing.A us distributor contacted zoll to report that a patient passed away in the hospital while wearing the lifevest on (b)(6) 2022.Review of the download data, indicates the patient received 10 appropriate treatments during vt/vf and 5 non-lifevest defibrillations.At 08:31:12, the patient's rhythm was sinus tachycardia at 120 bpm with motion artifact transitioning to vt at 190 bpm with motion artifact.Motion artifact and varying rates/amplitudes prevented the lifevest from treating the patient.From 08:31:47 to 08:32:16, the patient's rhythm was vt from 190-230 bpm with motion artifact.At 08:32:52, the patient received the first appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 230 bpm with motion artifact.The patient's post-shock rhythm was sinus bradycardia at 40 bpm.At 08:36:27, the patient received the second appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 240 bpm.The patient's post-shock rhythm was sinus bradycardia at 40 bpm.At 08:38:12, the patient received the third appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 210 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with pvcs and motion artifact.At 08:43:34, the patient received the fourth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus rhythm at 70 bpm with motion artifact.At 08:44:05, the patient received the fifth appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 210 bpm.The patient's post-shock rhythm was sinus rhythm at 70 bpm with motion artifact.At 08:46:19, the patient received the sixth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with pvcs transitioning to vt at 220 bpm.At 08:46:50, the patient received the seventh appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 210 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with pvcs.At 08:48:50, the patient received the eighth appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 210 bpm with motion artifact.The patient's post-shock rhythm was sinus rhythm at 70 bpm with pvcs and motion artifact.At 08:51:23, the patient received the ninth appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 200 bpm.The patient's post-shock rhythm was sinus bradycardia at 40 bpm with pvcs.At 09:07:29, the patient received the tenth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with cpr/motion artifact.The patient's post-shock rhythm was an idioventricular rhythm at 20 bpm with cpr/motion artifact.From 09:21:16 to 09:21:56, the patient's rhythm was an idioventricular rhythm at 40 bpm degrading to vf with varying amplitude.Varying amplitude prevented the lifevest from treating the patient.At 09:22:38, the patient received the first non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was vf with motion artifact.Post shock rhythm was sinus bradycardia at 30 bpm with unconducted p waves and motion artifact.The patient received a non-lifevest defibrillation 2 seconds into the detection sequence.From 09:23:47 to 09:28:41, the patient was intermittently in vt.Varying amplitudes, cpr, and electrode lead fall off prevented the lifevest from treating the patient.At 09:30:29, the patient received the second non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was unknown due to being obscured by motion artifact/electrode lead fall off.Post shock rhythm was unknown due to being obscured by cpr/electrode lead fall off.At 09:34:50, the patient received the third non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was unknown due to being obscured by motion artifact/electrode lead fall off.Post shock rhythm was unknown due to being obscured by cpr/electrode lead fall off.At 09:37:59, the patient received the fourth non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was unknown due to being obscured by motion artifact/electrode lead fall off.Post shock rhythm was unknown due to being obscured by cpr/electrode lead fall off.From 09:57:22 to 09:58:01, the patient was in vf.Motion artifact/electrode lead fall off prevented the lifevest from treating the patient.At 09:58:02, the patient received the fifth non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was vf with motion artifact/electrode lead fall off.Post shock rhythm was vf with motion artifact/electrode lead fall off.The patient was in vf for approximately 40 seconds before receiving the defibrillation.From 09:58:24 to 10:07:02, the patient rhythm was vf with motion artifact/electrode lead fall off.Motion artifact/electrode lead fall off prevented the lifevest from treating the patient.Per continuous ecg recording, the rhythm slows to an idioventricular rhythm from 70-10 bpm with motion artifact/ electrode lead fall off.The rhythm degrades to asystole with cpr/electrode lead fall off from 10:07:13 until the electrode belt is disconnected at 11:29:27 on (b)(6) 2022.

Manufacturer Narrative

During servicing of a monitor, which was returned for investigation into a patient death, a reportable malfunction was found.The monitor failed incoming functional testing.Upon investigation the monitor failed incoming functional testing.The cause for the failure was isolated to an open r781 driven ground resistor on the computer/analog board.The root cause for the open resistor could not be positively identified.The open r781 resistor is consistent with the patient receiving an external defibrillation while wearing the lifevest.There is no indication that the monitor malfunction contributed to the patient passing as the patient as in a non-treatable rhythm at the time the electrode belt was disconnected.The electrode belt has not been recovered.The device flag data from the last download does not indicate any device malfunction.

Event Description

During servicing of an electrode belt, which was returned for investigation into a patient death, a reportable malfunction was found.The monitor failed incoming functional testing.A us distributor contacted zoll to report that a patient passed away in the hospital while wearing the lifevest on (b)(6) 2022.Review of the download data, indicates the patient received 10 appropriate treatments during vt/vf and 5 non-lifevest defibrillations.At 08:31:12, the patient's rhythm was sinus tachycardia at 120 bpm with motion artifact transitioning to vt at 190 bpm with motion artifact.Motion artifact and varying rates/amplitudes prevented the lifevest from treating the patient.From 08:31:47 to 08:32:16, the patient's rhythm was vt from 190-230 bpm with motion artifact.At 08:32:52, the patient received the first appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 230 bpm with motion artifact.The patient's post-shock rhythm was sinus bradycardia at 40 bpm.At 08:36:27, the patient received the second appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 240 bpm.The patient's post-shock rhythm was sinus bradycardia at 40 bpm.At 08:38:12, the patient received the third appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 210 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with pvcs and motion artifact.At 08:43:34, the patient received the fourth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus rhythm at 70 bpm with motion artifact.At 08:44:05, the patient received the fifth appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 210 bpm.The patient's post-shock rhythm was sinus rhythm at 70 bpm with motion artifact.At 08:46:19, the patient received the sixth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with pvcs transitioning to vt at 220 bpm.At 08:46:50, the patient received the seventh appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 210 bpm.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with pvcs.At 08:48:50, the patient received the eighth appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 210 bpm with motion artifact.The patient's post-shock rhythm was sinus rhythm at 70 bpm with pvcs and motion artifact.At 08:51:23, the patient received the ninth appropriate treatment.The patient's rhythm at the time of the treatment event was vt at 200 bpm.The patient's post-shock rhythm was sinus bradycardia at 40 bpm with pvcs.At 09:07:29, the patient received the tenth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with cpr/motion artifact.The patient's post-shock rhythm was an idioventricular rhythm at 20 bpm with cpr/motion artifact.From 09:21:16 to 09:21:56, the patient's rhythm was an idioventricular rhythm at 40 bpm degrading to vf with varying amplitude.Varying amplitude prevented the lifevest from treating the patient.At 09:22:38, the patient received the first non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was vf with motion artifact.Post shock rhythm was sinus bradycardia at 30 bpm with unconducted p waves and motion artifact.The patient received a non-lifevest defibrillation 2 seconds into the detection sequence.From 09:23:47 to 09:28:41, the patient was intermittently in vt.Varying amplitudes, cpr, and electrode lead fall off prevented the lifevest from treating the patient.At 09:30:29, the patient received the second non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was unknown due to being obscured by motion artifact/electrode lead fall off.Post shock rhythm was unknown due to being obscured by cpr/electrode lead fall off.At 09:34:50, the patient received the third non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was unknown due to being obscured by motion artifact/electrode lead fall off.Post shock rhythm was unknown due to being obscured by cpr/electrode lead fall off.At 09:37:59, the patient received the fourth non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was unknown due to being obscured by motion artifact/electrode lead fall off.Post shock rhythm was unknown due to being obscured by cpr/electrode lead fall off.From 09:57:22 to 09:58:01, the patient was in vf.Motion artifact/electrode lead fall off prevented the lifevest from treating the patient.At 09:58:02, the patient received the fifth non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was vf with motion artifact/electrode lead fall off.Post shock rhythm was vf with motion artifact/electrode lead fall off.The patient was in vf for approximately 40 seconds before receiving the defibrillation.From 09:58:24 to 10:07:02, the patient rhythm was vf with motion artifact/electrode lead fall off.Motion artifact/electrode lead fall off prevented the lifevest from treating the patient.Per continuous ecg recording, the rhythm slows to an idioventricular rhythm from 70-10 bpm with motion artifact/ electrode lead fall off.The rhythm degrades to asystole with cpr/electrode lead fall off from 10:07:13 until the electrode belt is disconnected at 11:29:27 on (b)(6) 2022.

• 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: steven kyle ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 13549776
• MDR Text Key: 285756871
• Report Number: 3008642652-2022-01786
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 01/31/2022
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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