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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Defibrillation/Stimulation Problem (1573); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 02/13/2018

Event Type  Death  

Manufacturer Narrative

Device evaluation summary: device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) has been completed.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 contributing to the patient death.

Event Description

Zoll was notified on (b)(6) 2018 that the patient passed away at home on the evening of (b)(6) 2018 while reportedly wearing the lifevest.It was reported that the patient's husband stated that "the vest did not work".It was reported that the device was alarming and that the patient's husband tried to wake the patient but she was unconscious.Ems was called and cpr was initiated by the family.Per clinical review of the available ecg, the device was started up at 06:33:07 on (b)(6) 2018.From 18:51:07 to 19:03:25, noise was detected in the front and side channels.Per download data, the patient was in sinus tachycardia at 110 bpm degrading to vf with motion artifact and varying amplitudes for approximately 12 minutes transitioning to asystole with intermittent cardiac activity degrading to asystole from 19:03:25 until the device shutdown at 19:25:35 on (b)(6) 2018.In addition, bradycardia was detected at 19:05:51.Motion artifact and varying amplitudes during the detection of vf prevented the device from delivering a treatment shock.Subsequent monitoring of the patient was not possible due to the device shutdown.

• 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: manuela parra ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7367917
• MDR Text Key: 103400147
• Report Number: 3008642652-2018-02944
• 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: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 03/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2013
• 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; Life Threatening; Other
• Patient Age: 63 YR