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

Model Number WCD 4000

Device Problems Component Falling (1105); Device Displays Incorrect Message (2591)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of belt sn (b)(4) has been completed.The reported problem (constant gong alarms) was confirmed.As received, the belt failed incoming therapy electrode (te) recognition testing.Upon evaluation, there was an open pulse wire in the cable connecting the distribution node (dn) and front te, between the dn and ecg electrode b.The cause of the constant gong alarms and incoming test failure is the open wire.The root cause of the open wire is excessive force placed on the cable.No adverse event resulted from the damaged wire.

Event Description

A us contacted zoll to report that a patient's device was producing constant gong alarms.In addition, the distributor reported that the patient had dropped the monitor on her toe and broke her toe.There was no alleged device malfunction associated with dropping the monitor.Follow up indicated that the patient's toe healed without medical intervention.

• 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: katelynn mains ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 6388779
• MDR Text Key: 69749652
• Report Number: 3008642652-2017-01948
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2013
• 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