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

Model Number WCD 4000

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Dizziness (2194)

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

There was no death or device malfunction associated with the inappropriate defibrillation.The patient was taken to the hospital for further evaluation.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 sn : 01/23/2015 - reuse.Electrode belt sn (b)(4): 09/25/2014 - reuse.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.

Event Description

A us distributor contacted zoll to report that a patient experienced an inappropriate defibrillation event.It was reported that the patient was wiping down the shower in a correction facility at the time of the event.The patient was reportedly lightheaded and dizzy at the time of the event.After review of the downloaded data, it was confirmed that the patient received one inappropriate treatment at 20:30:52 on (b)(6) 2015.Atrial fibrillation with a rapid ventricular response contributed to the false detection.A review of the downloaded data confirms that the response buttons were pressed intermittently, but the response buttons were not pressed during the treatment sequence that resulted in the inappropriate defibrillation treatment.The patient was sent to the hospital for further evaluation.

• 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: hana casalnova ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4997110
• MDR Text Key: 22776031
• Report Number: 3008642652-2015-04824
• 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
• Report Date: 08/03/2015

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: Not provided
• Initial Date FDA Received: 08/12/2015
• Date Device Manufactured: 01/23/2015
• 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: 67 YR