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 Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 03/23/2020

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 investigated.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 product malfunction.Manufacture dates: monitor sn (b)(4) - 04/27/2010, electrode belt sn (b)(4) - 03/26/2011.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020.The patient was reportedly in a hospital at the time of passing.Per clinical review of the patient's continuous ecg recordings, the lifevest detected an arrythmia at 15:29:00 on (b)(6) 2020.At the time of the detection the patient's rhythm was sinus rhythm at 95 bpm degrading to ventricular tachycardia (vt) at 190 bpm.The response buttons were pressed intermittently from 15:29:44 to 15:30:33.It is unknown who was pressing the response buttons at this time.The patient then received a non-lifevest defibrillation.The patient's rhythm at the time of the non-lifevest defibrillation was vt at 190 bpm, and the patient's post shock rhythm was sinus tachycardia at 120 bpm with preventricular contractions.The patient did not receive a treatment from the lifevest due to the response button use.The device was shut down at 15:30:07 on (b)(6) 2020.The patient's rhythm at the time of the device shut down was sinus tachycardia at 120 bpm.There is no indication or allegation that a device malfunction caused or contributed to the patient's passing.Due to the response button use during a treatable rhythm, reporting event out of abundance of caution.

• 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: eliza schally ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10026391
• MDR Text Key: 189920473
• Report Number: 3008642652-2020-03857
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 03/30/2020
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2010
• 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
• Patient Age: 77 YR