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 05/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) and belt (b)(4) has been completed.The reported problem (constant gong alarms / belt would not stay connected) was confirmed.As received, the belt receptacle was pulled and separated from the monitor case, damaging internal wires.The monitor receptacle was attached to the belt connector and could not be dislodged.The cause of the constant gong alarms and inability of the electrode belt to stay connected to the monitor was the damaged receptacle and wires.The root cause of the damaged receptacle and wires is excessive force placed on the cable.The root cause of the receptacle being attached to the electrode belt connector is the reported gluing by the patient.No adverse event resulted from the defective monitor or belt.

Event Description

A us distributor contacted zoll to report that a patient's device was producing constant gong alarms.Follow up with the patient indicated that the electrode belt would not stay connected to the monitor and so the patient glued the belt to the monitor.

• 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: 6718748
• MDR Text Key: 80255994
• Report Number: 3008642652-2017-05930
• 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: 07/13/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2013
• 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