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

Model Number WCD 4000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/11/2014

Event Type  Injury  

Event Description

A zoll pt service rep (psr) called zoll customer support to report that, sometime after the pt was treated by the lifevest, the pt fell and broke her wrist.At the time of initial investigation, it was not apparent that the pt sustained the injury as a direct result of the lifevest.Additional info received on (b)(4) 2014 alleged that the pt's injury was sustained as a result of the lifevest.As a result of this additional info, zoll decided to report this event.

Manufacturer Narrative

Device eval summary: device eval 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 electrode belt appropriately deployed defibrillator gel prior to the treatment event.A device of the event determined that the pt was treated twice by the lifevest on (b)(6) 2014 at 14:07:49 and 14:10:52 due to dual-lead noise and artifact.The response buttons were not pressed during the detection sequence prior to each pulse delivery.The root cause for the dual-lead noise could not be positively identified, but the artifact event may have been caused by a loose garment that resulted in ecg electrode movement.The pt was conscious at the time of the event.It is not clear exactly when the pt fell and broke her wrist.Device manufacture date: monitor sn (b)(4); electrode belt sn (b)(4).

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL LIFECOR CORPORATION; pittsburgh PA 15238 349
• Manufacturer Contact: zachary nelson ; 121 gamma dr; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 3736308
• MDR Text Key: 4221131
• Report Number: 3008642652-2014-01073
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• 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: 02/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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): Required Intervention
• Patient Age: 69 YR