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

Model Number WCD 4000

Device Problem Insufficient Information (3190)

Patient Problem Sudden Cardiac Death (2510)

Event Date 01/26/2018

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (patient death) was investigated.As received, the monitor passed incoming functional testing.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the device, 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.Belt sn (b)(4) has not yet been recovered.Initial evaluation included a review of the downloaded data which did not indicate any device malfunction that would cause or contribute to the patient's death.

Event Description

A us distributor contacted zoll to report that a patient passed away at home while wearing the lifevest.The patient was reportedly discharged from the hospital while not feeling well.The patient's wife reportedly observed a treatment from the lifevest and then removed the battery to perform cpr.Review of the event indicates that the patient entered vt at 140bpm which transitioned to an idioventricular rhythm at 85bpm between 07:38:34 and 07:42:00.The patient's rate was below the prescribed programmed threshold of 150bpm and a treatment sequence was not initiated.The patient then entered vf at 07:42:40 and the device delivered one 150j shock.The post-shock rhythm was asystole.Post-shock asystole is considered a known and potentially adverse outcome of defibrillation therapy.The patient remained in asystole until the electrode belt was disconnected.

• 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: katelynn mains ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 7370668
• MDR Text Key: 103468171
• Report Number: 3008642652-2018-02890
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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