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

Model Number WCD 4000

Device Problems Self-Activation or Keying (1557); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

A (b)(6) year old female pt contacted zoll customer support to report that the device was constantly going.During troubleshooting, the pt reported that she could not longer connect the electrode belt and the device was prompting a service code 204.The pt was provided with a replacement electrode belt.

Manufacturer Narrative

Device evaluation of electrode belt sn (b)(4) has been completed.The reported problem (going / code 204 / cannot connect) has been confirmed.Upon evaluation, pin 13 was bent and contacting pins 10 and 2.The cause of the code 204 is a disruption in communication between the monitor and electrode belt.The cause of the disruption in communication is a short in the trunk connector.The cause of the short is the bent pin.The cause of the inability to connect the belt is the bent pin.The root cause of the bent pin cannot be positively identified but is likely excessive force when mating the belt with the monitor while the pins were misaligned.No adverse event resulted from the damaged electrode belt connector.The pt received a replacement electrode belt.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL LIFECOR CORP; pittsburgh PA 15238 349
• Manufacturer (Section G): ZOLL LIFECOR CORPORATION; 121 gamma dr; pittsburgh PA 15238 000
• Manufacturer Contact: 121 gamma dr; pittsburgh, PA 15238-0000
• MDR Report Key: 3737848
• MDR Text Key: 15206080
• Report Number: 3008642652-2014-00632
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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 Age: 47 YR