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

Model Number WCD 4000

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Death (1802)

Event Date 06/04/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) was completed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, 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.There is no indication of a monitor malfunction.Device evaluation of electrode belt sn 59136942 has been completed.As received, the electrode belt failed incoming functionality testing, as it was unable to communicate with a monitor.The cause for the failure to communicate with a monitor was isolated to open pulse wires, an open yellow (pgnd) wire, and open orange (+5v) wire, an open brown (-5v) wire, and an open black (main batt) wire in the trunk cable.The trunk cable showed signs of physical abuse.The root cause for the open wires was excessive force.It is unknown how the damage to the electrode belt cable occurred.Due to the damage to the device, it is unknown if the patient was in a treatable rhythm during the event.It cannot be positively determined whether the damage to the electrode belt caused or contributed to the patient death.Device manufacture date: sn (b)(4): 05/01/2015, sn (b)(4): 10/13/2015.

Event Description

A us distributor contacted zoll and reported that the patient passed away in a nursing facility on (b)(6) 2017 while wearing the lifevest.It was reported that the patient was checked on at 3:30am on (b)(6) 2017 by a nurse at the facility.The patient was checked on again at 05:30am and was found to be unresponsive.It was reported that the lifevest had some type of error message on the screen, but it was not reported what the error message was.Per the downloaded flag files and ecg recordings, the patient was in sinus tachycardia at 120 bpm at 01:44:03 on (b)(6) 2017 when the device first recorded electrode belt communication errors, causing an abnormal shutdown.After the abnormal shutdown, the device re-started and electrode belt communication fault flags continued from 01:44:11 to the time of the device shutdown at 08:52:34.As received, the electrode belt sn (b)(4) failed incoming functionality testing as it was unable to communicate with a monitor.The cause for the failure to communicate was isolated to open pulse wires, an open yellow (pgnd) wire, and open orange (+5v) wire, an open brown (-5v) wire, and an open black (main batt) wire in the trunk cable.The abnormal shutdown and belt communication errors are indicative of the damage to the electrode belt.The patient was in a non-treatable rhythm at the time of the abnormal shutdown, however the rhythm after the shutdown is unknown.No sustained ventricular tachycardia or ventricular fibrillation was detected while the patient was being monitored prior to the abnormal shutdown of the device.

• 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: johnna dominick ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 6713740
• MDR Text Key: 80305327
• Report Number: 3008642652-2017-05938
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005012
• UDI-Public: 00855778005012
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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: 59 YR