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

Model Number WCD 4000

Device Problems Leak/Splash (1354); Loss of Power (1475); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem Death (1802)

Event Date 04/01/2018

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(6) has been completed.The monitor was returned for evaluation at the distributor.During functional testing, a 1 hz simulated normal sinus rhythm signal was applied to the monitor, followed by a 5 hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5 hz 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.There is no indication of a product malfunction contributing to the patient death.Device evaluation of belt sn (b)(4) has been completed.The belt was returned for evaluation at the distributor.Upon evaluation, gel was confirmed to be leaking from the front therapy electrode.During functional testing, a 1 hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5 hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.The pulse delivery circuitry test verified proper delivery of a full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.There was no indication of any product malfunction that would contribute to the reported adjust belt messages.The following factors could not be ruled out as potential contributing sources of the reported gong alarms: poor ecg contact with skin patient activity/body motion loss of driven ground signal due to poor therapy electrode contact with skin there is no indication of any product malfunctions contributing to the patient death.

Event Description

A us distributor reported that a patient passed away the morning of (b)(6) 2018.Prior to passing, at around 12 am on (b)(6) 2018, the patient called customer service and notified the distributor that his electrode belt was leaking gel and that he was removing the device because it was producing non-stop gong alarms.Per the distributor, the patient refused assistance with troubleshooting the alarms and did not want a visit from customer support to assist with the gonging alarms because he just wanted to sleep.Multiple attempts to contact the patient the following morning were unsuccessful.During a follow up with the patient's alternative contacts, the patient's sister reported that the patient passed away sometime the morning of (b)(6) 2018.Review of the downloaded flag data confirms that the patient shutdown the device at 12:02:07 am on (b)(6) 2018.Prior to shutting down the device, the flags indicate that the patient was experiencing intermittent noise on the ecg channels, which would cause the reported gong alarms.

• 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: allison petzold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7480735
• MDR Text Key: 107148632
• Report Number: 3008642652-2018-03988
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR