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

Model Number WCD 4000

Device Problems Thermal Decomposition of Device (1071); Display or Visual Feedback Problem (1184); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2019

Event Type  Injury  

Manufacturer Narrative

There was no death or serious injury associated with the alleged event.Device evaluation summary: electrode belt (b)(4) was returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.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.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.Device evaluation of monitor (b)(4) has been completed.The reported problem (treatment) was unable to be confirmed.As received, the monitor was unable to power on.Upon evaluation multiple components on the defibrillator and computer/analog pcas were thermally damaged.The cause of the damage was isolated to liquid contamination on the j1003bb connector on the computer analog board.The contamination caused high voltage to travel to the low voltage circuitry on the computer analog board, causing the thermal damage.The root cause of the contamination was ingress of an unknown liquid.Lifevest patient training materials have been updated as a reminder not to expose the lifevest electronic components to liquids.Additional inappropriate defibrillation narrative: the primary cause of the shock event is unknown due to the loss of ecg and flag data.The primary cause of the detection is unknown due to the loss of ecg data.Unable to confirm any treatment delivery.

Event Description

A us distributor contacted zoll to report that a patient experienced a defibrillation event on (b)(6) 2019.The patient reported that the device alarmed, the monitor "popped", and almost knocked him to the ground.The patient did not report any injuries.The patient reported that there was a small amount of blue gel on the therapy electrode pads.The patient also confirmed not feeling any symptoms.Following the reported "pop", the monitor would not power up.Following the alleged treatment, the patient did not seek medical intervention and continued wearing the lifevest.The ecg and flag data surrounding the alleged treatment was unavailable for review due to thermal damage within the monitor.The occurrence of treatment is unable to be confirmed.This event is being reported out of an abundance of caution as zoll is unable to positively determine if the defibrillation treatment occurred and if it was appropriate or inappropriate.There was no death or serious injury associated with the alleged defibrillation event.

• 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: 8439252
• MDR Text Key: 139417662
• Report Number: 3008642652-2019-02038
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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): Other
• Patient Age: 41 YR