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); Loss of Power (1475); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problem Death (1802)

Event Date 07/27/2019

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (patient death) was investigated.As received, the monitor passed incoming functional testing.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the device, 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.Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (service code 204) has been confirmed.Upon investigation the electrode belt was unable to communicate with a monitor.The cause for the failure was isolated to an open green (+3.3v) wire in the trunk cable.The root cause for the open wire was excessive force.It is unknown when this damaged occurred.The electrode belt was able to record the patient's heart rhythms and treat the patient on the last day of use.There is no indication that the device malfunction caused or contributed to the adverse event.Device manufacture date: monitor: 04/03/2013, belt: 02/25/2014.

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest on (b)(6) 2019.It was reported that the patient's passing was cardiac related and that the lifevest was alarming, but that the patient was unconscious.The patient's grandmother was present at the time of passing.Review of the download data, indicates the patient received four shocks in response to nsvt, cpr/motion artifact, and low amplitude cardiac signal.The device detected 3 arrhythmias between 05:58:44 to 06:01:22 on (b)(6) 2019 while the patient was in vt from 110 to 150 bpm.The device detected an arrhythmia at 06:02:00 while the patient was in vt at 110 bpm.Gel was released at 06:03:07.The patient received the first treatment while in an idioventricular rhythm at 90 bpm.The patient's post shock rhythm was an idioventricular rhythm at 60 bpm degrading to asystole for approximately 3.05 seconds transitioning to an idioventricular rhythm at 60 bpm degrading to asystole for approximately 3.32 seconds transitioning to an idioventricular rhythm at 20 bpm with pvc's.The patient was in asystole at the time of the second, third and fourth treatment shocks at 07:17:20, 07:17:48, and 07:18:15.The patient's post shock rhythm for all three shocks was asystole.The device was shutdown at 07:27:02 on (b)(6) 2019 while the patient was in asystole.The response buttons were not pressed during the event.The device properly detected vt and vf although the rates were not sustained above the prescribed rate threshold long enough for the lifevest to complete the treatment sequence.There is no indication that the lifevest caused or contributed to the patient death.There is no indication that the lifevest treatments during asystole caused or contributed to the death as, the patient was already in a non-life-sustaining rhythm.No deficiencies were alleged against the lifevest.The patient passed away on (b)(6) 2019.

• 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: brooke arnold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8941131
• MDR Text Key: 155927931
• Report Number: 3008642652-2019-06781
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• 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: 08/01/2019
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2013
• 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: 64 YR