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

Model Number WCD 4000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Dizziness (2194); Shock from Patient Lead(s) (3162)

Event Date 03/14/2020

Event Type  Injury  

Manufacturer Narrative

There was no death or device malfunction associated with the defibrillation event.Device evaluation summary: monitor sn (b)(4) and electrode belt sn (b)(4) were returned to the distributor for evaluation.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor and 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 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.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.Manufacture date: monitor - (b)(4) - 06/27/2017, belt - (b)(4) - 03/28/2018.

Event Description

A us distributor contacted zoll to report that a patient experienced an appropriate defibrillation event consisting of one shock.The patient reported becoming lightheaded at the time of the event.The patient's rhythm at the time of the treatment was vt at 170 bpm and their post-shock rhythm was vt at 170 bpm.The patient received medical attention at a hospital and continues to wear the lifevest.As the treatment was unsuccessful in converting the patient's arrhythmia, reporting event out of abundance of caution.There was no death or device malfunction associated with the event.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: eliza schally ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10080294
• MDR Text Key: 196549642
• Report Number: 3008642652-2020-04592
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2017
• 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): Hospitalization; Other
• Patient Age: 63 YR