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

Model Number WCD 4000

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

There was no death or device malfunction associated with the defibrillation event.Monitor sn (b)(4) and electrode belt sn (b)(4) were returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the treatment event.During the incoming 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.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 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.Device manufacture date: monitor: 04/17/2015, belt: 05/12/2016.A review of the patient's downloaded flag file confirmed that the device declared a treatable arrhythmia and subsequently delivered three treatment defibrillations.The associated ecg strips of the treatment event are inconclusive due to the strips showing false asystole.It was reported that the patient was in the process of putting the lifevest back on at the time of the event, and the electrodes were likely not making proper contact.As such, the exact rhythm at the time of the event cannot be confirmed.

Event Description

A us distributor contacted zoll to report that a patient experienced an unknown defibrillation event consisting of three shocks.The patient was reportedly conscious and combative at the time of the treatment event.The patient's nurse was present at the time of the event.The patient's nurse reported that the patient was putting the lifevest on again at the time of the event and that the electrodes were facing outward.Review of the download data indicates that the patient received three low energy pulses across 0 ohm impedance, indicating that the therapy electrodes were not making proper contact with the patient at the time of the treatment.This is consistent with reports by the nurse.Following the event, the patient continued wearing the lifevest.There was no death or device malfunction associated with the 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: gabrielle salazar ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7309282
• MDR Text Key: 101371725
• Report Number: 3008642652-2018-02127
• 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: 03/02/2018

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2015
• 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: 67 YR