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

Model Number WCD 4000

Device Problem Signal Artifact/Noise (1036)

Patient Problem Death (1802)

Event Date 07/02/2020

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (patient death) was confirmed.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.Electrode belt (b)(4) has been returned to zmc and the evaluation is underway.Device evaluation included review of downloaded software flag files on the day of the event.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 patient death.Manufacture dates: monitor 01/21/2016, electrode belt 12/07/2016.

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest on (b)(6) 2020.It was reported that the patient was at home and later at the hospital with ems at the time of passing.Ems reportedly attempted to resuscitate the patient.Per the dir received on (b)(6) 2020, the review of the patient's continuous ecg recordings shows that the patient was in idioventricular rhythm at 30 bpm degrading to asystole with motion artifact.The rhythm then transitioned to an idioventricular rhythm at 90 bpm.The patient received a non-lifevest defibrillation.The rhythm at the time of treatment was vt at 120 bpm.Post shock rhythm was vt at 140 bpm slowing to vt at 110 bpm with cpr/motion artifact.The patient's rhythm was below the physician prescribed treatment threshold of 150 bpm, and the cpr and motion artifact obscured the patient's rhythm and prevented the lifevest from delivering a treatment.The patient rhythm was briefly seen in vt at 180 bpm with cpr/motion artifact.The rhythm then degraded to asystole with cpr/motion artifact from approximately 13:17:11 until the electrode belt was disconnected at 13:38:39 on (b)(6) 2020.The cpr and motion artifact obscured the patient's rhythm and prevented the lifevest from delivering a treatment.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: matthew saich ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10437707
• MDR Text Key: 203872998
• Report Number: 3008642652-2020-07245
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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: 07/20/2020
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• 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; Hospitalization; Other
• Patient Age: 73 YR