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

Model Number WCD 4000

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Death (1802); Dizziness (2194); Loss of consciousness (2418); Shock from Patient Lead(s) (3162)

Event Date 09/10/2020

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) has been completed.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.There is no indication of a product malfunction.Manufacture dates: monitor - (b)(4) - 02/04/2016, belt - (b)(4) - 07/27/2016.

Event Description

A us distributor contacted zoll to report that a (b)(6) patient passed away on (b)(6).Clinical review of the patient's download data reveals that the patient received one inappropriate treatment on (b)(6) while they were in asystole.The patient was reportedly lying in bed when treated and became dizzy and unconscious.The patient's neighbor witnessed the event and resuscitation was initiated by emergency medical services.The lifevest was reportedly removed by the emergency physicians.Oversensing of low amplitude cardiac signal contributed to the false detection.The response buttons were not pressed during the event.The patient subsequently passed away.The patient's equipment was returned and found to be fully functional.There is no indication of a device malfunction that would cause or contribute to the patient's passing.

• 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: eliza schally ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 10669580
• MDR Text Key: 211006955
• Report Number: 3008642652-2020-08732
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): Y
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2016
• 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; Other
• Patient Age: 75 YR