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

Model Number WCD 4000

Device Problems Image Display Error/Artifact (1304); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Asystole (4442)

Event Date 02/09/2021

Event Type  Death  

Manufacturer Narrative

The monitor sn (b)(4) was returned and evaluated at the distributor.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the audio messaging and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a product malfunction.Device evaluation of electrode belt sn (b)(4) has been completed.All gels were deployed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes.The pulse delivery circuitry test verified proper delivery of full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.There is no indication of a product malfunction.Manufacture dates: monitor: 11/20/2014, electrode belt: 3/28/2019.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2021 while wearing the lifevest.It was reported that medical staff was present with the patient when they passed away.Review of the patient's download data revealed that on the day of passing, the patient received an inappropriate treatment from the lifevest at 06:06:00.The patient's rhythm at the time of the treatment was obscured by cpr and motion artifact, the patient's post-shock rhythm was asystole.The patient remained in asystole until the electrode belt was disconnected at 06:06:23.The response buttons were not pressed during the event.Cpr and motion artifact contributed to the false detection.There is no indication that the lifevest caused or contributed to the patient's passing as the patient was in a non-life-sustaining rhythm prior to treatment delivery.

• 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: mary ward ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 11611101
• MDR Text Key: 243718709
• Report Number: 3008642652-2021-02915
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• 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: 03/01/2021
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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; Other