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 Arrhythmia (1721); Ventricular Tachycardia (2132); Loss of consciousness (2418); Shock from Patient Lead(s) (3162)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

The monitor sn (b)(4) was returned and evaluated at the distributor.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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.The distributor functionality testing confirmed that the device was fully functional.The monitor pulse delivery and ecg acquisition circuitry was fully functional.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 event.Manufacture dates: monitor: 6/20/2012; belt: 10/14/2014.

Event Description

A us distributor contacted zoll to report that a patient received a treatment from the lifevest on (b)(6) 2019.The patient was reportedly in the hospital and unconscious with hospital staff present at the time of the event.At 7:32:00 pm, the patient received the treatment.The patient's rhythm at the time of the treatment was ventricular tachycardia (vt) at 150 bpm.The post-shock rhythm was sinus rhythm at 100 bpm transitioning to vt at 180 bpm with cpr artifact.A non-treatable rhythm was declared at 7:32:30 pm.At 7:49:57 pm, an arrhythmia was detected by the lifevest.The patient's ecg shows that the patient's rhythm was sinus rhythm at 50 bpm transitioning to vt at 190 bpm.The patient then received an external defibrillation.The patient's rhythm at the time of the treatment was vt at 200 bpm with cpr artifact.The post-shock rhythm was an idioventricular rhythm at 55 bpm with cpr artifact.A non-treatable rhythm was declared at 7:50:23 pm.The lifevest was shutdown at 9:46:16 pm on (b)(6) 2019.It was reported that the patient was taken to the icu and is on a ventilator.The patient has ended use of the lifevest.It is not known at this time how long the patient was in vt before the external defibrillation was delivered.It is also not known at this time why the lifevest did not treat the second run of vt.Attempts are being made to gather this information.A supplemental mdr will be submitted upon receipt of this information.

Event Description

A us distributor contacted zoll to report that a patient received a treatment from the lifevest on (b)(6) 2019.The patient was reportedly in the hospital and unconscious with hospital staff present at the time of the event.At 7:32:00 pm, the patient received the treatment.The patient's rhythm at the time of the treatment was ventricular tachycardia (vt) at 150 bpm.The post-shock rhythm was sinus rhythm at 100 bpm transitioning to vt at 180 bpm with cpr artifact.A non-treatable rhythm was declared at 7:32:30 pm.At 7:49:57 pm, an arrhythmia was detected by the lifevest.The patient's ecg shows that the patient's rhythm was sinus rhythm at 50 bpm transitioning to vt at 190 bpm.The patient then received an external defibrillation.The patient's rhythm at the time of the treatment was vt at 200 bpm with cpr artifact.The post-shock rhythm was an idioventricular rhythm at 55 bpm with cpr artifact.A non-treatable rhythm was declared at 7:50:23 pm.The lifevest was shutdown at 9:46:16 pm on (b)(6) 2019.It was reported that the patient was taken to the icu and is on a ventilator.The patient has ended use of the lifevest.It is not known at this time how long the patient was in vt before the external defibrillation was delivered.It is also not known at this time why the lifevest did not treat the second run of vt.Attempts are being made to gather this information.A supplemental mdr will be submitted upon receipt of this information.(b)(6) 2016 additional information includes: further review of the available ecg data concludes that cpr artifact prevented further detection and treatment.This aligns with the observed resuscitation attempts.

Manufacturer Narrative

The monitor sn (b)(4) was returned and evaluated at the distributor.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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.The distributor functionality testing confirmed that the device was fully functional.The monitor pulse delivery and ecg acquisition circuitry was fully functional.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 event.Manufacture dates: monitor: 6/20/2012 belt: 10/14/2014 (b)(6) 2019 belt evaluation: belt sn (b)(4) was returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing of the electrode belt.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 event.During the incoming functional testing of the electrode belt, the ecg acquisition and pulse delivery circuitry were verified.

• 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
• MDR Report Key: 8633369
• MDR Text Key: 145846130
• Report Number: 3008642652-2019-03961
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR