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

Model Number WCD 4000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Idioventricular Rhythm (1923); Asystole (4442)

Event Date 11/13/2021

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away in a rehab facility on (b)(6) 2021.Review of the patient's download data indicates the patient received one inappropriate shock in response to oversensing of low amplitude cardiac signal and motion artifact on the date of passing.The device was started up at 14:54:38 on (b)(6) 2021.The patient was in sinus rhythm/bradycardia at 70 to 30 bpm at 18:40:02.The patient's rhythm degraded to severe bradycardia at 10 bpm with unconducted p waves.The rhythm then transitions to an idioventricular rhythm at 60 bpm before degrading back to asystole with unconducted p waves by 18:44:42.The patient received the inappropriate shock at 19:25:38.The patient's rhythm at the time of the shock and post-shock rhythm were asystole with motion artifact.The patient was last seen in asystole with cpr/motion artifact at 19:30:19.The electrode belt was disconnected at 19:31:28 on (b)(6) 2021.

Manufacturer Narrative

The monitor and electrode belt has been returned and the evaluation is underway.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 07/21/2020.Belt 08/05/2019.

• 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: 13009361
• MDR Text Key: 282261949
• Report Number: 3008642652-2021-10978
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: 12/07/2021
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2020
• 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