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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Sudden Cardiac Death (2510)

Event Date 02/27/2018

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and belt sn (b)(4) has been completed.The reported problem (patient death) was investigated.As received, the monitor and belt passed 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.

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest.The patient reportedly took the battery out of the lifevest to use the bathroom.The patient's son found the patient unresponsive and called the paramedics.The patient's son placed the battery back into the device and the device shocked the patient twice but it was reportedly 'too late'.The son and paramedics both reportedly attempted cpr.Review of the event indicates that the patient entered vf at 12:48:30 at which point the response buttons were pressed.It is unknown who pressed the response buttons.The device again detected vf at 12:50:05 and delivered a 150j shock at 12:50:39.The post-shock rhythm was asystole with intermittent cardiac activity.Cpr artifact and the return of an ideioventricular rhythm at 30bpm was then observed on the ecg recording.The patient's rhythm degraded to severe bradycardia at 10bpm until the patient re-entered vf at 13:01:00.A second 150j shock was delivered at 13:01:53.The post-shock rhythm again was asystole.The patient remained in asystole until the electrode belt was disconnected at 13:07:25.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.

• 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: 7370665
• MDR Text Key: 103469490
• Report Number: 3008642652-2018-02868
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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: 03/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2012
• 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