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

Model Number WCD 4000

Device Problem Image Display Error/Artifact (1304)

Patient Problem Death (1802)

Event Date 01/22/2020

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) has been completed.The reported problem (patient death) was confirmed.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, 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 tactile vibration alarm, 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 manufacture date: monitor: 5/6/2015, belt: 9/15/2016.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020, while wearing the lifevest.It was reported that the patient passed away while at home.It was reported that the patient's daughter was present.Resuscitation efforts were attempted.Clinical review of the ecg data indicates that the patient was seen in vt at 110 bpm with cpr/motion artifact degrading to vf with cpr/motion artifact from 17:43:00 to 17:49:23.The lifevest detected an arrhythmia at 17:49:23 with response button use ,while the patient was in vf with motion artifact.The lifevest detected an arrhythmia at 17:50:36, while the patient was in vf with motion artifact.The lifevest delivered the first treatment at 17:51:10, while the patient was in vf.The patient's post shock rhythm was asystole transitioning to vf.The patient was treated a second time at 17:51:42, while the patient was in vf with motion artifact.The patient's post shock rhythm was asystole transitioning to vf with motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The electrode belt was disconnected at 17:51:53.The patient passed away on (b)(6) 2020.

• 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: brooke arnold ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 9830148
• MDR Text Key: 183316909
• Report Number: 3008642652-2020-02183
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• 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: 02/13/2020
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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: 71 YR