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

Model Number WCD 4000

Device Problems Device Alarm System (1012); Signal Artifact/Noise (1036); Loss of Power (1475)

Patient Problem Skin Discoloration (2074)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

There was no death associated with the defibrillation event.Device evaluation summary: device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (treatment event) was confirmed.All gels were deployed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes.The pulse delivery circuitry test verified proper delivery of full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.There is no indication of a product malfunction.Device evaluation of monitor sn (b)(4) has been completed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, 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.  there is no indication of a product malfunction.Upon review of a patient's flag files, it appears that the patient was treated in the field, and the monitor reset after delivering the treatment.The root cause for the reset was isolated to noise originating from the defibrillator pca high-voltage capacitors and propagating on the main battery wire on the monitor c/a board.(b)(4).

Event Description

A us distributor contacted zoll to report that a patient experienced an arrhythmia alarm and an abnormal shutdown.The patient reported that the device treated him while he was watching tv.The patient reported that blue gel was present and that the device was prompting him to get a new lifevest.The patient reported pressing the response buttons, but that the lifevest treated him anyways.The patient reported having brown marks on his skin that resembled the therapy electrodes.Per review of the patient's flag files, an arrhythmia was detected at 04:14:34 on (b)(6) 2019.The patient's ecg files show that the arrhythmia that was detected was ventricular tachycardia {vt) from 170 bpm to 220 bpm with motion artifact.The arrhythmia detection resulted in flags that are consistent with a pulse reset.Based on the available information surrounding the event, the patient was treated by the device during vt, however the device reset following the treatment caused the "pulse delivered" flag and the ecg data during the event not to be recorded.The patient's monitor and electrode belt were returned and found to be fully functional and able to detect an arrhythmia and deliver a treatment shock.The patient survived the event and continues wearing the lifevest.The patient did not seek medical attention following the event.There is no death or serious injury associated with this 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: brooke arnold ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 8898260
• MDR Text Key: 154545880
• Report Number: 3008642652-2019-06477
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• 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?: Yes
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• 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: 61 YR