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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Defibrillation/Stimulation Problem (1573)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 12/05/2013

Event Type  Death  

Event Description

During a retroactive review of past complaints for potential adverse event, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.A zoll territory manager contacted zoll customer support to report that a (b)(6) male pt was found dead in his car on (b)(6) 2013 while wearing the lifevest.The pt had reportedly gone to the emergency room the night before for shortness of breath but was not admitted.At 11:47:58 on (b)(6) 2013, the pt's rhythm degraded to vt (160 bpm) with cpr artifact.Lifevest detection stopped at 11:52:48.The electrode belt was disconnected at 12:04:44.The lifevest properly detected the ventricular arrhythmia.However, cpr artifact delayed a treatment from being delivered.It is unk who performed cpr.The pt reportedly passed away at 12:21 pm on (b)(6) 2013.

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) was completed.The monitor and electrode belt were fully functional upon receipt.There is no indication of any device malfunction.Electrode belt sn (b)(4) manufactured 09/2013.Monitor sn (b)(4) - reuse.Electrode belt sn (b)(4) - initial use of device.

• 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: 4251861
• MDR Text Key: 4988428
• Report Number: 3008642652-2014-03610
• 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,Company Representative
• Type of Report: Initial
• Report Date: 11/03/2014

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/23/2013
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR