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

Model Number WCD 4000

Device Problems Retraction Problem (1536); Defibrillation/Stimulation Problem (1573)

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

Event Date 07/14/2015

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) was accomplished through a review of patient's downloaded data.Review of the data does not indicate any device malfunction related to the defibrillation event.

Event Description

A us distributor contacted zoll to report that a (b)(6) patient was treated and passed away while in the icu on (b)(6) 2015.The lifevest detected ventricular fibrillation (vf) and delivered a 150j pulse at 23:01:23.The arrhythmia was converted to bradycardia.A second treatment was delivered at 23:14:21 during sinus tachycardia with bbb.Elevated heart rate with bbb contributed to the false detection.The patient's post-shock rhythm remained sinus tachycardia.The lifevest detected cpr artifact after the second treatment, and the response buttons were pressed.The patient was externally defibrillated in the icu at 23:28:25 during a run of vf.Cpr artifact interrupted the lifevest vf detection.The patient's post-shock rhythm could not be determined due to cpr artifact.The electrode belt was disconnected at 23:35:36 and the patient subsequently passed away.

• 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: zachary nelson ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5015930
• MDR Text Key: 23511759
• Report Number: 3008642652-2015-05116
• Device Sequence Number: 1
• Product Code: MVK
• 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
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• 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?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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