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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); High impedance (1291)

Patient Problem Death (1802)

Event Date 12/17/2019

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (patient death) was confirmed.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.There is no indication of a monitor malfunction.Electrode belt sn (b)(4) has not been returned for evaluation.Device evaluation includes review of downloaded software flag files on the days surrounding the event.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 patient treatment/death.Device manufacture date: monitor: 07/25/2017, belt: 11/07/2015.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2019.The patient's husband was present at the time of the patient's passing.It was reported that the lifevest was alarming and that the patient was initially alert but then became unconscious.The nurses at the patient's facility reportedly attempted resuscitation.Review of the patient's download data reveals that the patient experienced an appropriate treatment event on (b)(6) 2019, the date of their passing.An arrhythmia was detected at 18:28:42 when the patient's rhythm was ventricular tachycardia (vt) at 160 bpm with cpr/motion artifact.The patient received a treatment at 18:29:52.The patient's rhythm at the time of the treatment was vt at 180 bpm with cpr/artifact.The patient's post-shock rhythm was ventricular fibrillation (vf) with cpr/motion artifact.The energy delivered in this treatment was 123 joules.The low energy pulse was caused by high impedance.The cause of the high impedance is unknown.There is no indication that the high impedance was caused by a device malfunction.The continuous ecg recordings show that the patient was in vf with cpr artifact at the time of the electrode belt disconnection immediately following the treatment.There is no indication that a device malfunction caused or contributed to the patient's death.

• 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: 9682867
• MDR Text Key: 178303602
• Report Number: 3008642652-2020-00876
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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: 01/07/2020
• Date Manufacturer Received: 01/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• 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: 35 YR