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 Insufficient Information (4580)

Event Date 07/18/2021

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) has been completed.The reported problem (patient death) was confirmed.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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.During the transition to the 5hz 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.  upon further investigation of the download data, the monitor had displayed service code 104, indicating a defective sd card.A defective sd card does not affect the monitor's ability to detect and treat an arrhythmia.Unavailability of retrospective ecg recordings did not cause or contribute to the this adverse event.The sd card is a data logger that only stores the patient's retrospective continuous ecg recordings.There is no real and active patient monitoring associated with the stored retrospective ecg recordings.  the root cause of the defective sd card could not be positively identified.Device manufacture date: monitor 04/04/2014, belt 04/15/2015.

Event Description

A us distributor contacted zoll to report that a patient had passed away at home while wearing the lifevest on (b)(6) 2021 around 9:00 pm.It was reported that the patient was treated by the lifevest on the date of passing.A review of the downloaded patient data flag files indicate that the patient received eight unknown treatment events at 01:04:59, 01:05:30, 15:15:29, 15:16:00, 15:16:27, 15:16:56, 15:17:25, and 15:21:17 on the date of passing ((b)(6) 2021).The device was shutdown at 15:59:38.The patient reportedly passed away around 9:00 pm.The specific rhythm at the time of the treatment events is unknown.The downloaded data indicates that the device had displayed multiple service code 104 (sd card fault) flags on the days prior to the date of passing.There were no allegations of device malfunction contributing to the patient's death.The device was fully functional upon receipt.Reporting this event out of an abundance of caution as the rhythm at the time of the treatment events on the patient's date of death is unknown.

• 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: matthew saich ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 12424678
• MDR Text Key: 270036356
• Report Number: 3008642652-2021-07666
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• 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: 08/02/2021
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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): Death