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

Model Number WCD 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 08/02/2017

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) is underway.Device evaluation of belt sn (b)(4) has been completed.The initial evaluation included review of downloaded software flag files on the day of the event and incoming functional testing of the belt.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the event.During the incoming functional testing of the belt, the ecg acquisition and pulse delivery circuitry were verified.Device manufacture date: monitor: 12/27/2015, belt: 01/29/2016.

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest.The patient was reportedly in the hospital at the time of the event and collapsed.The device reportedly treated the patient before the hospital staff removed the lifevest and attempted to shock the patient.The patient reportedly passed away while staff was performing cpr.Review of the event indicates that the patient received ten shocks during asystole.Cpr artifact contributed to the detections.Asystole is considered a non-life sustaining rhythm.

• 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: katelynn mains ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 6839406
• MDR Text Key: 84490615
• Report Number: 3008642652-2017-07317
• 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: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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
• Patient Age: 66 YR