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

Model Number WCD 4000

Device Problem Device Stops Intermittently (1599)

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

Event Date 12/29/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor (b)(4) is underway.The reported problem (abnormal shutdowns / won't power on) was confirmed.As received, the monitor would not power on.Root cause investigation is underway.No adverse event resulted from the defective monitor.

Event Description

A us distributor contacted zoll to report that a patient's monitor was experiencing abnormal shutdowns.During servicing, it was confirmed that the monitor would not power on.

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) was completed.The reported problem (abnormal shutdowns / won't power on) was confirmed.Upon investigation the monitor was unable to power on.The cause for the failure was isolated to corrosion inside of the monitor.The root cause for the corrosion was ingress of an unknown liquid.No adverse event resulted from the defective monitor.

Event Description

A us distributor contacted zoll to report that a patient's monitor was experiencing abnormal shutdowns.During servicing, it was confirmed that the monitor would not power on.

• 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: zachary nelson ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 5434741
• MDR Text Key: 38645140
• Report Number: 3008642652-2016-00767
• 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,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• 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: 01/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2011
• 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