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

Model Number WCD 4000

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problems Arrhythmia (1721); Fall (1848); Dizziness (2194)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

A us distributor contacted zoll to report that a patient experienced a treatment event.The patient reported that the he was walking into the house after doing yard work and felt a boom and fell on the floor.The patient reported that his heart was doing 'something funny' earlier and that he had felt dizzy all day.Per review of the patient's flag files, an arrhythmia was detected at 13:09:31 on (b)(6) 2020.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 an unknown rhythm, 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
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: brooke arnold ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10019356
• MDR Text Key: 190806370
• Report Number: 3008642652-2020-03982
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• 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?: Yes
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2014
• 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