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

Model Number WCD 4000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/17/2014

Event Type  Injury  

Event Description

Zoll was contacted by a us distributor to report that, sometime after being treated by the lifevest, an (b)(6) year old male patient reported being thrown by the treatment and experienced bruising and a bump on his head.Later the patient reported losing consciousness, vision impairment, headaches, and foot pain.Following the treatment, the patient sought follow-up care with his eye doctor, cardiologist and surgeon.The patient alleged there were no alarms (tactile or audible) warning of the pending treatment.The patient continues to wear the device.

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) was completed.Upon investigation the monitor and electrode belt were fully functional.No problems were found with the device.The monitor's audio and tactile alarms were fully functional.The electrode belt appropriately deployed defibrillator gel prior to the treatment event.A review of the event determined that the patient was treated once by the lifevest on (b)(6) 2014, at 10:27:05 am, due to motion artifact.The response buttons were pressed intermittently after the treatment occured.The root cause for the motion artifact not be positively identified, but the artifact event may have been caused by a loose garment that resulted in ecg electrode movement.The patient was conscious at the time of the event.The patient continues to wear the device.Device manufacture date: monitor sn (b)(4): 07/01/2009.Electrode belt sn (b)(4): 05/01/2013.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: lindsey folio ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 3952038
• MDR Text Key: 17389926
• Report Number: 3008642652-2014-02168
• 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,Distributor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/14/2014

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: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2014
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 07/17/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR