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

Model Number WCD 4000

Device Problems Defibrillation/Stimulation Problem (1573); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problems Asystole (1727); Death (1802); Ventricular Fibrillation (2130)

Event Date 04/15/2012

Event Type  Death  

Event Description

During a retroactive review of past complaints for potential adverse events, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.The wife of a (b)(6) male pt called zoll customer support to report that the pt passed away on (b)(6) 2012.The device was alarming and the pt was unconscious.Paramedics transported the patient to the hospital, where he later passed away.The lifevest detected an arrhythmia (vt degrading to vf) at 00:55:09 on (b)(6) 2012.The response buttons were pressed at 00:55:15, delaying treatment.A second treatable arrhythmia (vf) was detected at 1:00:30.The response buttons were used again to delay treatment at 1:00:55.A 150j treatment was delivered at 01:01:56.The rhythm at the time of treatment was vf.The post-shock rhythm was asystole.The pt remained in asystole.The electrode belt was disconnected at 01:13:19.The lifevest was shutdown at 01:43:45.The use of the response buttons prevented a treatment for approximately 5 minutes.It is unk who pressed the response buttons, as the patient was reportedly unconscious.Bystanders are alerted through alarms not to interfere with the lifevest.Post-shock asystole is a known possible outcome of defibrillation.

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) was completed.The monitor was fully functional upon receipt.Electrode belt sn (b)(4) was never returned for investigation.There is no evidence of any device malfunction.Electrode belt sn (b)(4) manufactured 03/2010.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: zachary nelson ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4251858
• MDR Text Key: 5013091
• Report Number: 3008642652-2014-03571
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• 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 Returned to Manufacturer: 09/05/2013
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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: 61 YR