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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Signal Artifact/Noise (1036); Output Problem (3005)

Patient Problem Bradycardia (1751)

Event Date 04/16/2022

Event Type  Death  

Manufacturer Narrative

The monitor has been returned and the evaluation is underway.The device flag data from the last download does not indicate any device malfunction.The electrode belt has not been recovered.The device flag data from the last download does not indicate any device malfunction.

Event Description

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 one appropriate treatment during vf.From 09:19:28 to 09:21:42, the patient was seen in vt from 210-240 bpm.Motion artifact and varying amplitudes prevented the lifevest from treating the patient.At 09:22:22, the patient received the appropriate treatment from the lifevest.The patients rhythm at the time of the treatment was vf.The patient's post-shock rhythm was sinus bradycardia at 20 bpm with pvcs and unconducted p waves.At 09:38:10, the patient received a non-lifevest defibrillation.Rhythm at the time of the defibrillation was svt at 200 bpm.Post shock rhythm was sinus tachycardia at 140 bpm with pvc¿s.The lifevest typically requires 60 seconds of sustained vt to deliver a shock.At 10:04:17, the device was shutdown.Patient was last seen in sinus tachycardia at 100 bpm with motion artifact and electrode lead fall off.The patient passed away 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
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 15208820
• MDR Text Key: 297681096
• Report Number: 3008642652-2022-21985
• Device Sequence Number: 1
• Product Code: MVK
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIFEVEST WCD 4000 SYSTEM
• Date Manufacturer Received: 08/09/2022
• 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