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 Problem Death (1802)

Event Date 09/20/2011

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.On (b)(6) 2011, a (b)(6) female pt's daughter contacted zoll and reported that the pt passed away wearing the lifevest while in the icu.It was reported that lifevest was 'going off but none of the nurses knew how to turn it off'.Review of the event indicates that the pt experienced eight inappropriate defibrillations on 09/19/2011.Svt contributed to the false detections.The responses buttons were not used during the entire event.The pt later passed away.

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and belt sn (b)(4) were completed.Upon evaluation, the monitor and electrode belt were fully functional.Review of the pt's ecg and downloaded data indicates that persistent svt triggered the false detections resulting in the inappropriate defibrillations on (b)(6) 2011.The pt didn't use the response buttons during the entire event.The post-shock rhythms were svt around 150-160bpm.The pt passed away (b)(6) 2011.The cause of the pt's death is unk.Belt: 01/2011.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: katelynn mains ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4250069
• MDR Text Key: 5016003
• Report Number: 3008642652-2014-03609
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/07/2011
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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: 73 YR