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

Model Number WCD 4000

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Ventricular Tachycardia (2132); No Code Available (3191)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Electrode belt sn (b)(4) has not yet been recovered from the field.Device evaluation included review of downloaded software flag files on the day of 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 death.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 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 product malfunction.Device manufacturer date monitor: 07/13/2010, electrode belt: 08/19/2010.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020.The patient was reportedly in the hospital and being monitored on telemetry.It was reported that the patient's passing was cardiac related.It was reported that the hospital staff performed resuscitation efforts.  the patient received 3 appropriate treatments from the lifevest.The patient was treated at 4:36:01 am on (b)(6) 2020, the patient's day of passing.The patient's rhythm at the time of the treatment was ventricular tachycardia (vt) at 210 bpm, and the rhythm was converted to sinus rhythm at 60 bpm with hb and bbb.The patient received the second treatment at 4:38:00 am while the rhythm was vt at 230 bpm.The rhythm was converted to sinus rhythm at 60 bpm, transitioning to supraventricular tachycardia (svt).At 4:39:51 am, the patient received the third treatment from the lifevest.The patient's rhythm at the time of the treatment was vt at 240 bpm and the rhythm was converted to sinus rhythm at 60 bpm with svt.A non-treatable rhythm was declared by the lifevest at 4:39:58.The electrode belt was disconnected at 04:40:21.The patient was in svt at 190 bpm degrading to vt at 290 bpm.The patient was in vt for 10 seconds before the electrode belt was disconnected.The lifevest was unable to deliver a shock due to not being in the detection sequence long enough before the electrode belt was disconnected.Due to the hospital staff removing the lifevest during a treatable rhythm, making the determination that the event is reportable.

• 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: rachel mahoney ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 10042953
• MDR Text Key: 191481253
• Report Number: 3008642652-2020-03952
• 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: 05/01/2020

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: 02/27/2020
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2010
• 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; Hospitalization
• Patient Age: 72 YR