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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Component Falling (1105); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 02/05/2015

Event Type  Injury  

Event Description

A u.S.Distributor contacted zoll to report that a patient experienced an inappropriate defibrillation event while in the bathroom.Motion artifact contributed to the false detection.The patient was reportedly conscious at the time of the event and had the device hanging on her walker.The device reportedly fell on the floor and she was treated.The response buttons were not pressed during the entire event.The patient did not seek medical attention and continues use of the lifevest.

Manufacturer Narrative

There was no death or device malfunction associated with the inappropriate defibrillation.There is no information to suggest that the patient sustained a serious injury.The patient did not seek medical attention and continues use of the lifevest.Device evaluation was accomplished through a review of the patient's downloaded data file.Review of the data does not indicate any device malfunction related to the defibrillation event.Device manufacture date: monitor (b)(4): 05/2013; electrode belt (b)(4): 05/2014.Additional inappropriate defibrillation narrative: inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.(b)(4).

• 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: 4564896
• MDR Text Key: 5551725
• Report Number: 3008642652-2015-00891
• 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: Distributor
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• 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: 02/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• 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): Other
• Patient Age: 67 YR