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 Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 03/09/2015

Event Type  Injury  

Event Description

A united states distributor contacted zoll to report a (b)(6) year old female pt was appropriately treated.The pt stated that she woke up and she had blue gel on her chest.The pt alleged that the leg was broken after she woke up.The pt does not remember being treated by the lifevest.The lifevest properly detected and treated ventricular tachycardia (vt) at 270 bpm.The post-shock rhythm was sinus rhythm at 65 bpm.The pt went to the hospital for further evaluation.The pt's medical outcome is unk at this time.The pt ended use of the device due to receiving and icd on (b)(6) 2015.At this time it is unk if the alleged broken leg occurred before or after the appropriate treatment for vt.

Manufacturer Narrative

Device evaluation summary: device evaluation of monitor sn (b)(4) and electrode belt sn (b)(4) has been completed.The monitor and electrode belt were both fully functional and able to detect and treat a pt.Device manufacturer date: monitor sn (b)(4): 07/2014 - reuse.Electrode belt sn (b)(4): 06/2013 - reuse.

• 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: 4687562
• MDR Text Key: 5640273
• Report Number: 3008642652-2015-01987
• 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: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• 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: 03/14/2015
• Date Manufacturer Received: 03/14/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR