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

Model Number WCD 4000

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Reset Problem (3019)

Patient Problems Lethargy (2560); Shock from Patient Lead(s) (3162)

Event Date 06/14/2013

Event Type  Injury  

Event Description

A retroactive review of patient flag files in the lifevest network identified a monitor reset following a treatment on (b)(6) 2013.The patient reported that he was treated.The patient remembered being weak following dialysis treatment.After the retrospective review of the patient's flag files, it was revealed that the patient received one inappropriate treatment at 15:38:52 on (b)(6) 2013.After the treatment was delivered, the monitor reset.The rhythm at the time of treatment was a paced rhythm at 60 bpm.The post-shock rhythm was a paced rhythm at 60 bpm.The patient was taken to the hospital and continued to wear the lifevest.

Manufacturer Narrative

The patient was taken to the hospital and continued to wear the lifevest.Device evaluation summary: device evaluation of belt sn (b)(4) has been completed.The belt was returned on 06/15/2013.Upon investigation, the electrode belt was fully functional.Device evaluation of monitor sn (b)(4) was completed.The monitor was returned as normal maintenance on 09/04/2013 and found to be fully functional.Zoll was unaware of the treatment and reset that occurred at that time.Monitor sn (b)(4) reset after a treatment was delivered.An investigation into monitors exhibiting the same issue found that the root cause for the reset is noise from the defibrillator pca high-voltage capacitors propagating on the main battery wire on the monitor c/a board.A real-time review request for a design change to address this issue was submitted to fda on 01/20/2015.No adverse event resulted from the pulse reset.Device manufacture date: monitor sn (b)(4): (b)(6) 2013 - initial use.Electrode belt sn (b)(4): (b)(6) 2013 - initial use.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 date (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: nina rudolph ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 4673034
• MDR Text Key: 5607574
• Report Number: 3008642652-2015-01771
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 67 YR