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

Model Number WCD 4000

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104); No Display/Image (1183); Device Emits Odor (1425); Failure to Power Up (1476); Noise, Audible (3273)

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

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.The reported problem (does not power on / popped / loud noise / smells) has been confirmed.As received, the monitor would not power on.Upon evaluation, there was contamination at the j1002 and j1003 connectors on the computer/analog (ca) board.The contamination caused high voltage to deviate to low voltage circuitry.The high voltage caused damage to multiple components within the unit.The root cause of the contamination is liquid ingress of an unknown contaminant.A patient safety alert was mailed to active patients on 04/24/2017 as a reminder to not expose the lifevest electronic components to liquids.No adverse event resulted from the defective monitor.

Event Description

A us distributor contacted zoll to report that a patient's monitor 'popped' and would not power on.The patient reported that 'internally the device died and exploded'.The patient reported that the device made a loud noise 'like a gunshot' and the screen went black.The patient reported that the monitor smelled like it had burned.

• 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: 6664111
• MDR Text Key: 78409724
• Report Number: 3008642652-2017-05393
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• 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: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2017
• 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