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

Model Number WCD 4000

Device Problems Defibrillation/Stimulation Problem (1573); Device Operates Differently Than Expected (2913)

Patient Problems Atrial Fibrillation (1729); Death (1802); Ventricular Tachycardia (2132)

Event Date 03/21/2014

Event Type  Death  

Event Description

During a retroactive review of past treatment events for potential adverse events, conducted as a capa in response to a recent fda inspection, a reportable adverse event was discovered.Zoll customer support was notified via download data that a (b)(6) female pt was treated.Further investigation determined that the pt passed away while in the hospital.Ventricular tachycardia (vt) with cpr artifact was detected at 16:43:52.The lifevest delivered a treatment at 16:46:57 during cpr artifact.The cpr artifact contributed to the false detection.A second treatment was delivered at 16:47:34 during vt (267 bpm).The treatment was unable to convert the arrhythmia.A third treatment was delivered at 16:48:05 during vt (267).The treatment converted the arrhythmia to an idioventricular rhythm (120 bpm).The pt's rhythm degraded to asystole several hours later and the pt passed away.

Manufacturer Narrative

Device eval summary: device eval of monitor sn (b)(4) and electrode belt sn (b)(4) was completed.The monitor and electrode belt were fully functional upon receipt.No deficiencies were alleged against the device.There is no indication that the lifevest caused or contributed to the pt death.Mfr date: monitor: 04/2010 - reuse; electrode belt: 08/2013 - reuse.

• 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: 4734060
• MDR Text Key: 5707792
• Report Number: 3008642652-2015-02501
• 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: Other,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• 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?: Yes
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• 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: 68 YR