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 Problem Bradycardia (1751)

Event Date 11/11/2021

Event Type  Death  

Manufacturer Narrative

The monitor and electrode belt has 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 09/24/2012, belt 09/15/2014.

Event Description

A us distributor contacted zoll to report that a patient passed away in the hospital while wearing the lifevest between (b)(6) 2021 and (b)(6) 2021.Review of the patient's download data indicates the patient received five inappropriate shocks in response to cpr/motion artifact on the date of passing.The device was started up at 10:43:44 on (b)(6) 2021.The patient was in sinus rhythm at 60 bpm with pvc's and cpr/motion artifact at 15:36:04 on (b)(6) 2021.The patient was in sinus bradycardia at 50 bpm with cpr/motion artifact at 15:37:39.The patient received the first inappropriate shock at 15:38:14.The patient's rhythm at the time of the shock was obscured by cpr/motion artifact.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with cpr/motion artifact.The patient received the second through fifth inappropriate shocks at 15:38:43, 15:39:09, 15:39:53, and 15:40:34.The patient's rhythm at the time of each shock and post-shock rhythms were obscured by cpr/motion artifact.

• 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: 13004428
• MDR Text Key: 282256195
• Report Number: 3008642652-2021-10922
• 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

• 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
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2012
• 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