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

Model Number WCD 4000

Device Problems Loose or Intermittent Connection (1371); Noise, Audible (3273)

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

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of belt sn (b)(4) has been completed.The reported problem (loose connection / constant alarms) was confirmed.As received, the belt failed incoming ecg fall-off testing.Upon evaluation, the trunk cable connector was cracked and the white (drvn gnd) wire was open inside the trunk cable.The cause of the constant alarms and incoming test failure is the damaged connector and open wire.The root cause of the damaged connector and open wire is excessive force placed on the cable.No adverse event resulted from the damaged cable.

Event Description

A us distributor contacted zoll to report that the connection on a patient's electrode belt was loose and the device was producing constant gong alarms.

• 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: 6598820
• MDR Text Key: 76388536
• Report Number: 3008642652-2017-04527
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• 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: 05/03/2017
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2014
• 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