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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Failure to Sense (1559); Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/02/2015

Event Type  Injury  

Event Description

A u.S.Distributor contacted zoll to report that a patient experienced an inappropriate defibrillation event while in a car.Motion artifact contributed to the false detection.The patient reportedly did not hear the alarms due ot the car radio being loud.The response buttons were not pressed during the entire event.The patient visited the hospital for further evaluation.The patient continues use of the lifevest.

Manufacturer Narrative

There was no death or device malfunction associated with the inappropriate defibrillation.The patient visited the hospital for further evaluation 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): 04/2014; electrode belt (b)(4): 06/2011.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).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf.

• 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: 4564847
• MDR Text Key: 5550737
• Report Number: 3008642652-2015-00895
• 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

• 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
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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): Hospitalization; Other
• Patient Age: 55 YR